Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012528160

FEI Number

3012528160

Entity Name

Philips North America LLC

City/State/Country

Murrysville, PA, US

Establishment Address

1001 Murry Ridge Lane, STE A, Murrysville, PA 15668, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

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 Printer Kit, Strip Chart, USB - 989803181881 Expression Information Portal Expression Informal Portal 867062 Philips IntelliSpace Perinatal Rev. K0 Small Architecture 867061 Philips IntelliSpace Perinatal Rev. K0 Large Architecture IntelliVue Patient Monitor MX550 (866066) IntelliVue Patient Monitor MX400 (866060) IntelliVue Patient Monitor MX450 (866062) IntelliVue Patient Monitor MX500 (866064) G7m Module IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800 IntelliVue Patient Monitors MX430, MX700, MX800, MP5, MP5SC DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System 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 BIS Module IntelliVue NMT Hand Adapter Philips MP2 MP5 MP5TMP5SC MP20 MP30 MP40 MP50 MP60 MP70 MP80 MP90 MX600 MX700 MX800 Intellivue Pat. Monitors IntelliVue X2 Multi-Measurement Module NMT Module (865383) NMT Patient Cable (989803174581) 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 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 Intellivue MX40 Patient Monitor 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele IntelliVue Patient Monitors, Philips IntelliBridge EC10 and EC5 ID Module Philips MP40, MP50, MP60, MP70, MP80, MP90, AND MX800 Philips IntelliVue TcG10 Measurement Module Care Assist Patient Information Center iX, 866389 Thermal Printer Kit, USB (989803205011) MR Patient Care Portal 5000 (866162) Holter 1810/ 2010 SW IntelliVue Multi-Measurement Module X3 (867030) IntelliVue Patient Monitor MX100 (867033) 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 867040 - IntelliVue Capnography Extension 867041 - IntelliVue Microstream Extension transmitters and receivers, electro CareEvent 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951 PageWriter TC35 Cardiograph, TC35 (860437) 867036, IntelliVue Multi-Measurement Module MMX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-01-27
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2012-08-08
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2018-11-28
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2018-11-28
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-08-23
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2023-08-23
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-08-23
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2023-08-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-08-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-08-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-08-23
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2023-08-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-08-23
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-08-23
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-08-23
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-08-23
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-08-23
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-08-23
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-08-23
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-08-23
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-08-23
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2023-08-23
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-08-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-08-23
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2023-08-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-08-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-07-23
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2015-07-23
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2015-07-23
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2015-07-23
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2015-07-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2015-07-23
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2015-07-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-07-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-11-21
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-11-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-11-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-11-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-11-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-11-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-11-21
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2019-11-21
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2009-03-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-01-22
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2009-10-29
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2009-10-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2009-10-29
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2009-10-29
GWR	Generator, Electroencephalograph Test Signal	Neurology	Class 1	882.1430	2012-08-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-08-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-08-31
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2012-08-31
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2012-08-31
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DRJ	System, Signal Isolation	Cardiovascular	Class 1	870.2600	2012-08-31
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2012-08-31
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2012-08-31
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2012-08-31
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2012-08-31
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2012-08-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-08-31
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2012-08-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2012-08-31
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-08-31
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2012-08-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-08-31
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2012-08-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2012-08-31
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-08-31
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2012-08-31
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2012-08-31
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2012-08-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-08-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2012-08-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-08-31
MLC	Monitor, St Segment	Cardiovascular	Class 2	870.2340	2012-08-31
KRC	Tester, Electrode, Surface, Electrocardiographic	Cardiovascular	Class 2	870.2370	2012-08-31
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2012-08-31
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2012-08-31
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2012-08-31
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2012-08-31
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2012-08-31
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2012-08-31
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2012-08-31
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2016-01-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-08-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2015-04-21
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2015-04-21
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2015-04-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-04-21
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2015-04-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2015-04-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-04-21
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2015-04-21
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2013-07-03
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-07-03
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-07-03
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
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
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2016-02-18
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-12-19
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-12-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-12-19
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-12-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-19
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-12-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-12-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-05
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-01-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-01-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2018-01-11
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2018-01-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-01-11
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2018-01-11
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2007-12-05
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-10-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-12-14
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-11-19
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-11-19
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2018-11-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-11-19
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2018-11-19
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2018-11-19
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012528160. Last updated year: 2026. Please use registration number 3012528160 when referencing this establishment in official correspondence.