Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016618143

FEI Number

3016618143

Entity Name

Philips North America LLC

City/State/Country

Cambridge, MA, US

Establishment Address

222 Jacobs Street, Cambridge, MA 02141, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133961

PMA Number

N/A

All Registered Proprietary Names

Flex Adapter Nissha Adult Electrode Quadtrode CV MRI ECG Electrode Pad - 989803179041 40494E, Limb Clamp Electrode QUADTRODE MRI ECG PAD,25/BOX - 989803179031 Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051 ePatch ECG Electrode Patch ECG Electrode MCOT Patch Patch electrode ePatch electrode 2-CH Patch Universal Patch BTP-1000P (Patch) Patch Philips ECG Comfort Patch Lead Wire Adapter Gel, ECG/EEG, Skin Prep, Tube, 3-Pack Quick Connect SpO2 Grip, Adult, 20/box - 989803166551 Quick Connect SpO2 Grip, Ped, 20/box - 989803166561 Quick Connect SpO2 Clip, Adult - 989803166531 Quick Connect SpO2 Probe, MRI - 989803161991 Quick Connect SpO2 Clip, Pediatric - 989803166541 CAB,4 LD,NEO.MRI ECG - 9222 SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501 GRIP SENSOR STARTER KIT - 989803162491 SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511 PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023 Quick Connect SpO2 Grip, Infant, 20/box - 989803166571 KIT,SAMPLE,AGENTS,3160 - 94018 Anesthetic Oxygen (O2) Sensor - 989803162051 CUFFF,CHILD,MRI,COLDER CONN - 989803169441 CAB,4 LD,MRI ECG - 9224 Quick Connect SpO2 Starter Kit - 989803167111 Quick Connect SpO2 Grip, Neo, 20/box - 989803166581 Wireless SP02 Module (Gen 2) - 989803163111 Wireless ECG Module - 989803163121 ADVANCED FILTER ECG CABLE - 989803170121 Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421 Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401 CAB,4 LD,CV MRI ECG - 9223 MRI Patient Monitoring System, Mode VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display VM4 Monitor w/NIBP, SpO2, ECG, Ptemp VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display 989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult 989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal 989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2 M4681A Microstream® EtCO2 Consumables CapnoLine® H O2 989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric 989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult 989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal CANNULA,DISP,INFANT (4200F) 989803197511 6-Lead Set, Patient Use Disposable, Bedside, AAMI 989803173151 5-Lead Set, Single Patient Use Disposable,Telemetry, AAMI 989803192151 5-Lead Set, Single Patient Use Disposable, Chest, IEC 989803173121 3-Lead Set, Single Patient Use Disposable, Bedside, AAMI 989803174211 5-Lead Set, Single Patient Use Disposable,Bedside, IEC 989803174201 3-Lead Set, Single Patient Use Disposable, Bedside, IEC 989803192141 5-Lead Set, Single Patient Use Disposable, Chest, AAMI 989803173131 5-Lead Set, Single Patient Use Disposable, Bedside, AAMI 989803197521 6-Lead Set, Single Patient Use Disposable, Bedside, IEC MX40 Release B7 Expression MR FlexTEMP System, Jacket - 989803178181 M4691A Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal 989803178011 Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal Long M4686A Microstream® EtCO2 Consumables NIV Line M4689A Microstream® EtCO2 Consumables CapnoLine H M4687A Microstream® EtCO2 Consumables NIV Line Airway, DEHUM TBG, ADU PED Zoll LoFlo 10 Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10 Airway, DEHUM TBG, PED INF Zoll LoFlo10 Cannula, CO2, INF, Zoll LoFlo, 10 Cannula, O2 CO2, INF, 10, Zoll LoFlo Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10 Airway, Adult Pediatric, Zoll LoFlo, 10 Airway, Pediatric Infant, Zoll LoFlo, 10 Cannula, CO2 Oral, PED, Zoll LoFlo, 10 Cannula, CO2, ADU, Zoll LoFlo, 10 Cannula, O2 CO2, PED, Zoll LoFlo, 10 Cannula, CO2, PED, Zoll LoFlo, 10 Cannula, O2 CO2, ADU, Zoll LoFlo, 10 Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10 DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System M2202A Radiolucent Foam Electrode Reusable Adult/Pediatric Airway Adapter Airway Adapter - Single Patient Use - Adult/Pediatric Airway Adapter - Single Patient Use - Neonatal ADULT AIRWAY ADAPTER, QTY 1, MAQUET CAPNOSTAT 5 Mainstream Sensor, Maquet INTELLIVUE MX40 PATIENT MONITOR 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele 989803199081 MX40 Adapter SpO2-only 989803171831 ECG 5 lead Grabber, AAMI, Tele 989803199101 MX40 Adapter 3L+SpO2 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele 989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele 989803171931 ECG 5 lead Grabber, IEC, Tele 989803171961 ECG 6 lead Grabber, IEC, Tele 989803171861 ECG 6 lead Grabber, AAMI, Tele 989803171821 ECG 5 lead Snaps, AAMI, Tele 989803199091 MX40 Adapter 5L+SpO2 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele CareEvent Snap Style Foam Electrode 989803101301 HI-Tack Foam Wet Gel ECG Electrode 40420A HI-Tack Foam Wet Gel ECG Electrode M4612A Solid Gel Foam Electrode 989803192551 Clear Tape Wet Gel ECG Electrode M4613A Solid Gel Foam Electrode 989803192931, SureSigns VS Temporal Temperature HH 989803180831, Genius 2 tympanic temperature probe 863286, SureSigns VS4 Government Bundle 13943B Solid Gel Tab Electrode, Resting ECG Philips NM3 Respiratory Monitor w/VentAssist NM3 Respiratory Profile Monitor B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced) 40477A Chemical/Thermal Paper M3708A Chemical/Thermal Paper M4816A Thermal Paper M2485A Chemical/Thermal Paper 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines M4817A Thermal Paper 989803185271 Thermal Roll Paper, 110 mm Wide 989803138171 Defibrillator Chemical/Thermal Paper M3707A Chemical/Thermal Paper M2481A Chemical/Thermal Paper M1710A Chemical/Thermal Paper M2483A Chemical/Thermal Paper 40457C Chemical/Thermal Paper 989803138181 Defibrillator Chemical/Thermal Paper ST80i Stress Test System w/ Printer, Lead Sets, Electrodes 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps ST80i Stress Test System Value Care Cuff Small Adult Value Care Cuff Adult Value Care Cuff Adult XL (extra long) Value Care Cuff Large Adult Value Care Cuff Pediatric Value Care Cuff Infant 989803182921 Microstream® EtCO2 FilterLine H Set 989803182941 Microstream® EtCO2 VitaLine H Set 989803182931 Microstream® EtCO2 FilterLine H Set 989803160261 Microstream® EtCO2 VitaLine H Set Long 989803159581 Microstream® EtCO2 VitaLine H Set 989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Small Adult - 989803182631 Expression MR Wireless ECG Patient Module - 989803183661 Expression MR200 New MRI Monitor Accessories - 866177 LoFlo Sample Line, Neo. Cannula, Box 20 - 989803183261 LoFlo Line, Adu Airway Adpt, Box 100 - 989803185381 LoFlo Sample Line, Adult Cannula, Box 20 - 989803183241 LoFlo Line, Ped Dvd Cannula, Box 100 - 989803185371 LoFlo Sample Line, Ped. Cannula, Box 20 - 989803183251 LoFlo Line, Adu Dvd Cannula, Box 20 - 989803183271 LoFlo Line, Adu Airway Adpt, Box 20 - 989803183291 LoFlo Line, Ped Dvd Cannula, Box 20 - 989803183281 LoFlo Line, Adu Dvd Cannula, Box 100 - 989803185361 CS770 IntelliSpace Critical Care and Anesthesia H Airway Adapter Pediatric/Infant Nafion Capnoflex Pediatric Nasal/Oral CO2 Cannula Capnoflex Adult Nasal/Oral CO2 Cannula Capnoflex Pediatric Nasal CO2/O2 Cannula Capnoflex Infant/Neonatal Airway Adapter Kit Capnoflex Infant Nasal CO2 Cannula Capnoflex Cannula Nasal CO2 Only Pediatric Capnoflex Cannula Nasal CO2 Adult Capnoflex Sampling Line Male Luer-lok Adapter Dehumidification Airway Adapter Adult/Pediatric Capnoflex Cannula Nasal CO2/O2 Adult Capnoflex Airway Adapter Adult/Pediatric Nafion Capnoflex Sample Line Male Luer Capnoflex Infant Nasal CO2/O2 Cannula Cannula Oral/Nasal CO2/O2 Adult Capnoflex D Pediatric / Adult Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Neonatal Neonatal Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Standard Size NICO Sensor Small Size NICO Sensor Pediatric Combined CO2/Flow Sensor Series 3 Neonatal Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Adult Large Size NICO Sensor CO2/Flow Sensor Pediatric CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181 CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171 13955C Neonatal/Pediatric Snap Electrode, Square 13953E Radiolucent Preattached Leadwire Electrode, Square 13953D Metallic Preattached Leadwire Electrode, Square 13952D Metallic Preattached Leadwire Electrode, Medium 13951C Neonatal/Pediatric Solid Gel Electrode 13952A Preattached Leadwire Electrode medium 13953B Preattached leadwire electrode square 13952B Preattached Leadwire electrode medium 13953A Preattached Leadwire electrode square M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG M4601A Reusable Leg Belt- 32mm X 15M M2208A Disposable abdominal belts,100/cs M1562B Reusable abdominal/leg belt- 50mm X 1.3M Thermal Printer Kit, USB (989803205011) MR Patient Care Portal 5000 (866162) Philips Biosensor BX100 40493E Foam Wet Gel ECG Electrode 40493D Foam Wet Gel ECG Electrode Expression MR ECG Leads, IEC, Neonatal - 989803193771 Expression MR ECG Leads, IEC, CV - 989803193751 Expression MR ECG Leads, AAMI, Neonatal - 989803193741 Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771 Expression MR Universal Gating Interface - 989803195521 Expression MR400 MRI Patient Monitoring System (Model MR400) Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341 Expression MR ECG Leads, AAMI - 989803193721 Expression MR ECG Leads, AAMI, Standard - 989803193731 Expression MR ECG Leads, IEC, Standard - 989803193761 FlexTEMP System, Sensor - 989803178171 Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761 Expression MR IBP Transducer Cable, 5ft - 989803194601 Expression MR FlexTEMP II Sensor - 989803194511 Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331 Expression MR400 New MRI Monitor Accessories - 866428 FloTrak Elite Module wI Capnostat 5 C02 Sensor CompuRecord System Patient Information Center iX (PIC iX) AirwayAdapter PED/INF Nafion 704-0026-00 CannulaNasal/Oral CO2/O2 ADU 704-0020-00 Cannula Nasal/Oral CO2 ADU 704-0017-00 AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 Sample Line Male Luer 704-0027-00 Cannula Nasal CO2 PED 704-0012-00 Cannula Nasal CO2 Adult 7040010-00 Cannula Nasal CO2/O2 INF 704-0015-00 Cannula Nasal CO2/O2 ADU 704-0014-00 Cannula Nasal CO2/O2 PED 704-0016-00 Airway Adapter Kit PED/INF 704-0024-00 Airway, ADU-PED, SLM LoFlo, 10 CannulaNasal/Oral CO2/O2 PED 704-0022-00 Sample Line Male Luer Nafion 704-0028-00 989803148821 Radiolucent Foam Electrode 989803183311 Multi Care Cuff, Infant 989803183361Multi Care Cuff, Large Adult 989803183351 Multi Care Cuff, Adult XL 989803183321 Multi Care Cuff, Pediatric 989803183371 Multi Care Cuff, Thigh 989803183331 Multi Care Cuff, Small Adult 989803183341 Multi Care Cuff, Adult M1572A Comfort Care Cuff, Pediatric M1573A Comfort Care Cuff, Small Adult M1575A Comfort Care Cuff, Large Adult M1574A Comfort Care Cuff, Adult M1571A Comfort Care Cuff, Infant M1576A Comfort Care Cuff, Thigh M1574XL Comfort Care Cuff, Adult XL IntelliBridge System IntelliVue MX400, MX450, MX500, MX550, Rev. R Philips CareEvent Application Software Version B1 CareEvent M1872S Neonatal Soft Single-Patient Cuff Size#4 989803167551 Neonatal Soft Single-Patient NIBP Cuffs M1868S Neonatal Soft Single-Patient Cuff Size#2 M1866S Neonatal Soft Single-Patient Cuff Size#1 M1872B Neonatal Single-Patient Cuff Size #4 M1873S Infant Soft Single-Patient Cuff Size #5 M1866B Neonatal Single-Patient Cuff Size #1 989803167541 Neonatal Single-Patient NIBP Cuffs M1868B Neonatal Single-Patient Cuff Size #2 M1870S Neonatal Soft Single-Patient Cuff Size#3 M1873B Infant Single-Patient Cuff Size #5 M1870B Neonatal Single-Patient Cuff Size #3 989803194641, Expression MR IBP DPT Kit, I/N, Box 20 989803194631, Expression MR IBP DPT Kit, A/P, Box 20 TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT B800-11 BilEclipse, 50 Pack IntelliVue Information Ctr iX Software Arrhythmia Detector and Alarm Philips SureSigns Central Holter 1810/ 2010 SW SureSigns VM4, VM6, VM8 Government Bundle 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC 989803204591 Microstream Advance Pediatric Nasal CO2 Filter Line 989803204611 Microstream Advance Adult Nasal CO2 Filter Line 989803204481 Microstream Advance Adult Nasal CO2 Filter Line 989803204561 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 989803204621 Microstream Advance Adult Nasal CO2 Filter Line 989803204431 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 989803204601 Microstream Advance Pediatric Nasal CO2 Filter Line 989803204351 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 989803204361 Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204631 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 989803204411 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 989803204421 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 989803204441 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 989803204371 Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204571 Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204501 Microstream Advance Pediatric Nasal CO2 Filter Line 989803204541 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 989803204391 Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204581 Microstream Advance Adult Nasal CO2 Filter Line 989803204401 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 989803204551 Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204491 Microstream Advance Adult Nasal CO2 Filter Line 989803204381 Microstream Advance Adult Oral-Nasal CO2 Filter Line Philips SureSigns Vs2+ SureSigns VS2+ SureSigns VSi transmitters and receivers, electro 989803183081 Mini NeoLead, AAMI metal lead 989803183121 NeoLead, AAMI radio lead 989803183101 989803183101 989803183141 Micro NeoLead, AAMI radio lead Care Assist Patient Information Center iX, 866389 Carescape CO2 - LoFlo Respironics LoFlo Sidestream CO2 Module for Goldway Respironics LoFlo Sidestream CO2 Module Respironics LoFlo Sidestream CO2 Module for GE Respironics Alice, LoFlo, C5 Sidestream Module LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL Cobranded LoFlo CO2 Sampling Cannula LoFlo CO2 Sampling Cannula ADULT NASAL LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL LoFlo CO2 Sampling Cannula PEDIATRIC NASAL Sample Line-Female Luer Connector Cobranded LoFlo Sampling Line Kit Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing LoFlo SAMPLING LINE KIT LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL LoFlo Airway Adapter Kit ADULT/PEDIATRIC LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo Airway Adapter Kit INFANT/NEONATAL LoFlo SAMPLING LINE KIT w/Dehumidification Tubing LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL IntelliVue MX750/MX850,Flexible Module Server FMX-4, Rev. R 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable 21075A Esophageal/Rectal 12 Fr Temperature Probe 21078A Skin Surface Temperature Probe 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable 989803203581 Skin Temperature Probe, Reusable, Autoclavable 21076A Esophageal/Rectal 10 Fr Temperature Probe IntelliVue Information Center Softw Philips IntelliVue Information Center iX, M3290B Software Version C0 Suresigns VSV CapnoTrak CO2/O2 Nasal Cannula CapnoTrak CO2 Oral Nasal Cannula CapnoTrak O2 Delivery Extension Line CapnoTrak CO2 Sampling Extension Line CapnoTrak Dehumidification Tubing CapnoTrak CO2 Nasal Cannula SAMPLING LINE MALE LUER-LOK ADAPTER DEH CapnoTrak Water Filter Assembly CapnoTrak CO2/O2 Oral Nasal Cannula Dehumidification Tubing - 1 ft. Pediatric and Adult CO2 Airway Adapter, Reusable Neonatal and Pediatric CO2 Airway Adapter, Reusable Neonatal Flow and CO2 Sensor, Disposable Proximal Flow Sensor, Neonatal 989803137631 Fetal Spiral Electrode 989803137651-DECG Reusable Leg plate Adapter Cable PageWriter TC70 Cardiograph, TC70 (860315, 860352) PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466) PageWriter TC30 Cardiograph, TC30 (860306) 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length 989803164281, USB Patient Data Cable, Class B 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long 989803151661, 12-Lead Complete Lead Set (IEC), Long 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length 989803151651, 12-Lead Complete Lead Set (AAMI), Long 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long Veridia Patient Monitoring System M1921A Microstream® EtCO2 FilterLine H Set Philips IntelliVue Information Center iX, M3290B Software Release C1 21096A Foley Catheter Temperature Probe 16FR M2255A Foley Catheter Temperature Probe 14FR 21097A Foley Catheter Temperature Probe 18FR M4555B Easy Care Cuff Adult M4576B Gentle Care Cuff, Adult XL M4578B Gentle Care Cuff, Large Adult XL 989803182291 Single Care Cuff, Small Adult 989803182301 Single Care Cuff, Adult 989803182311 Single Care Cuff, Adult XL 989803182321 Single Care Cuff, Large Adult 989803182281 Single Care Cuff, Pediatric M4558B Easy Care Cuff Lrg Adult XL M4557B Easy Care Cuff Lrg Adult M4552B Easy Care Cuff, 1 Hose, Infant (1) M4553B Easy Care Cuff, 1 Hose, Pediatric (1) M4574B Gentle Care Cuff Small Adult M4573B Gentle Care Cuff Pediatric M4556B Easy Care Cuff Adult XL M4577B Gentle Care Cuff Large Adult M4554B Easy Care Cuff Sm Adult M4572B Gentle Care Cuff Infant M4559B Easy Care Cuff Thigh M4575B Gentle Care Cuff Adult IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J7 IntelliVue Patient Monitor MP2, SW Rev. J7 IntelliVue CL Respiration Pod, SW Rev. B IntelliVue Multi-Measurement Module X2, SW Rev. J7 IntelliVue GuardianSoftware SW Rev. A2 989803179541 Mobile CL Respiration Pod Attachment M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter Flex Adapter BTP-1000A-Hybrid Patch Lead Wire Adapter OMNI-TRAK 3000 SERIES SureSigns VS Temporal Temperature HH - 989803192931

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2022-02-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-01-27
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-07-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-07-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-07-31
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-07-31
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2013-07-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-07-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-07-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-07-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-07-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-05-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-05-30
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-03-23
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2018-05-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-05-14
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2018-05-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-05-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-05-14
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2018-05-14
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2018-05-14
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-10-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-09-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-09-23
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2009-03-11
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2011-11-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-12-08
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-08-31
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-10-14
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-02-19
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-02-19
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2015-11-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-11-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2015-11-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-11-03
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-04-06
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2012-01-25
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2009-07-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2008-04-16
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1992-10-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-01-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-11-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-05-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-03-31
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-05
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-02-01
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-02-01
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2018-05-11
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2016-03-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2016-03-31
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-03-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-03-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-03-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-03-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-03-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-03-31
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-03-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2016-03-31
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2014-09-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2009-10-29
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-03-22
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2009-10-29
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2021-10-13
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-10-13
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-04-22
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-02-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2016-01-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-02-06
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2015-02-06
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2009-05-27
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-10-15
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2019-10-15
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2019-10-15
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-10-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-10-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-10-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-09-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-09-22
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2020-09-22
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-03-22
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2009-10-29
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-01-05
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-05-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-05-22
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-22
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-05-22
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-05-22
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2026-05-22
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-05-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-22
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2026-05-22
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-05-22
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-22
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-05-22
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-05-22
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-22
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-05-22
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-05-22
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-05-22
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-05-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-22
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2026-05-22
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2026-05-22
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-05-22
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2026-05-22
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-02-26
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-06-09
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-03-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-01-28
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2012-02-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2012-02-21
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2012-02-21
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-02-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-02-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-02-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-08-19
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2016-02-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-11-13
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-03-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-03-24
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2011-10-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-10-20
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2011-10-20
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-10-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-10-20
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2011-10-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-10-20
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2007-12-05
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2013-10-24
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-03-07
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2022-03-07
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-03-07
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-03-07
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2022-03-07
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-03-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-05-22
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-05-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-05-22
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-05-22
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2026-05-22
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-22
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-05-22
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-05-22
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-05-22
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2026-05-22
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2026-05-22
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2026-05-22
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-22
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-05-22
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-22
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-05-22
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-22
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2026-05-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-05-22
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-05-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-05-22
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-22
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-05-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-06-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-11-13
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2008-11-13
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2008-11-13
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2008-11-13
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2008-11-13
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-07-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2016-07-14
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2016-07-14
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2016-07-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-07-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2016-07-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-02-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2014-09-11
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2009-02-19
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2021-07-12
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2009-02-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2009-10-29
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-05-11
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-05-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-05-11
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2018-05-11
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2018-05-11
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2011-06-09
OED	Antimicrobial Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2008-01-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2014-12-12
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2003-11-12
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-11-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-11-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-11-21
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2014-11-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-11-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-11-21

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US Agent Details

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Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15

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Recall ID	Recalling Firm	Recall Class	Product Description
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Z-0272-2024	Philips North America Llc	2	DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
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Z-0274-2024	Philips North America Llc	2	DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Z-0275-2024	Philips North America Llc	2	DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Z-0276-2024	Philips North America Llc	2	DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
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Z-0280-2022	Philips North America Llc	2	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Z-0280-2024	Philips North America Llc	2	ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Z-0281-2022	Philips North America Llc	2	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Z-0292-2024	Philips North America Llc	2	Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Z-0293-2024	Philips North America Llc	2	Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Z-0294-2024	Philips North America Llc	2	Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Z-0355-2022	Philips North America Llc	2	BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Z-0356-2022	Philips North America Llc	2	BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Z-0357-2022	Philips North America Llc	2	Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System
Z-0392-2024	Philips North America Llc	2	Ingenia 1.5T CX
Z-0393-2024	Philips North America Llc	2	Intera 1.5T
Z-0394-2024	Philips North America Llc	2	Intera 1.5T Power/Pulsar
Z-0395-2024	Philips North America Llc	2	SmartPath to dStream for 1.5T
Z-0416-2022	Philips North America Llc	2	Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
Z-0459-2023	Philips North America Llc	2	Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Z-0460-2023	Philips North America Llc	2	Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Z-0461-2023	Philips North America Llc	2	Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Z-0462-2023	Philips North America Llc	2	Philips MR 7700 System, Model Number 782120
Z-0463-2023	Philips North America Llc	2	Philips Upgrade to MR 7700 System, Model Number 782130
Z-0471-2022	Philips North America Llc	2	Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Z-0476-2022	Philips North America Llc	2	Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0505-2024	Philips North America Llc	2	Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016618143. Last updated year: 2026. Please use registration number 3016618143 when referencing this establishment in official correspondence.