Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219324

FEI Number

1219324

Entity Name

RESPIRONICS NOVAMETRIX, LLC

City/State/Country

Andover, MA, US

Establishment Address

3000 Minuteman Rd., Andover, MA 01810, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K050762

PMA Number

N/A

All Registered Proprietary Names

FloTrak Elite Module wI Capnostat 5 C02 Sensor Capnostat 5 Mainstream CO2 Sensor for Mindray Medical Capnostat 5 Mainstream CO2 Sensor for Goldway Medical Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable 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 CAPNOSTAT 5 Mainstream CO2 sensor IntelliVue Patient Monitors Philips INF Nasal CO2 O2 Cannula Philips Sample Line Kit, M2776A Philips PED INF A ADPTR W HUMID, M2773A Philips ADU Oral Nasal CO2 Can, M2756A Philips ADU Nasal CO2 Cannula, M2744A Philips PED Nasal CO2 O2 Cannula, M2751A Philips ADU Nasal CO2 O2 Cannula, M2750A Philips ADU PED A ADPTR W Humid, M2772A Philips ADU Oral Nas CO2 O2 Can, M2760A Philips PED Oral Nasal CO2 Can, M2757A Philips PED INF Airway Adapter Philips PED Oral Nas CO2 O2 Can, M2761A Philips ADU PED Airway Adapter, M2768A CO2 Nasal Cannula - Infant Philips Sample Line W HUMID Kit, M2777A CO2 Nasal Cannula - Pediatric 15mm Male/Female Adapter CapnoTrak Airway Adapter Set Reusable Neonatal CO2 Airway Adapter Neonatal Airway Adapter Pediatric/Adult Airway Adapter NOVA DISP AIRW ADPTRADLT 20/C Neonatal/Pediatric Airway Adapter Reusable Airway Adapter MaInstream CO2 Adult Pediatric/Adult Airway Adapter with Mouthpiece 15mm Male/Female Adapter Low Deadspace AA &TRAY ASSY, ADU, ZOLL MED 8000-0262 Adapter ADU Reuse Capnostat 704-0002-00 Neonatal and Pediatric CO2 Airway Adapter, Disposable Infant Airway Adapter, Disposable Zoll Neonatal Reusable Adapter, Qty 1 Pediatric and Adult CO2 Airway Adapter, Disposable 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 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 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 ADULT AIRWAY ADAPTER, QTY 1, MAQUET Reusable Adult/Pediatric Airway Adapter Airway Adapter - Single Patient Use - Adult/Pediatric Airway Adapter - Single Patient Use - Neonatal M3014A Capnography Extension IntelliVue Patient Monitor Reusable NEO Airway Adapter, Philips Single-Patient Use Adult Airway Adapter Mainstream CO2 Sensor Reusable ADU-PED Airway Adapter, Philips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-21
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2020-07-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-07-23
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-07-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-03-05
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2003-11-10
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
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2014-09-11
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
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	2009-10-29

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 →

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
K050762	Philips Medizin Systeme Boeblingen GmbH	PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90	2005-04-22
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219324. Last updated year: 2026. Please use registration number 1219324 when referencing this establishment in official correspondence.