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RESPIRONICS NOVAMETRIX, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12193241219324RESPIRONICS NOVAMETRIX, LLC1Y2026-01-013000 Minuteman Rd. Andover MA US 01810

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00884838104723Airway Adapters - Pediatric/Adult Airway Adapter+1(724)744-2500Respironics.Service@philips.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
865321297887063K992101CRITERION 40 OR PM 40CAP2000-01-06
865321087570410K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
865321408683575K963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610CCK1996-11-20
865321045850173K950397SYSTEM 22 VALVEBYE1995-04-14
865321601561334K910019NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MONCCK1991-03-26
865321212146795K193228Hamilton-G5CBK2020-05-04
865321568523532K181216HAMILTON-T1, HAMILTON-C1CBK2019-08-02
865321263637701K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19
865321345037665K162832731 Series VentilatorsCBK2017-08-02
865321855217182K123149SERVO-I VENTILATOR SYSTEMCBK2014-06-20
865321488535988K103578PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTBZK2011-06-02
865321386432249K092217MERCURY VCO2BZK2009-08-21
865321808241421K091459PHILIPS NM3 MONITOR, MODEL 7900BZK2009-07-28
865321491942711K083750CAPNOSTAT / CAPNOFLEX CO2 SYSTEMMHX2009-03-23
865321747224846K060221THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORSMHX2006-02-17
865321948105782K053174LOFLO C5 CO2 SENSORCCK2006-01-12
865321189643295K050762PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90MHX2005-04-22
865321109157645K042601CAPNOSTAT 5CCK2004-11-19
865321524298374K032971TIDAL WAVE SP MODEL 710/715 AND 715DQA2004-08-26
865321411689688K031124POLARIS 95000-A BEDSIDE/TRANSPORT MONITORMHX2003-12-04
865321501663335K023565OXICHECKCCL2003-03-28
865321937393653K000959CRITERION 60 OR PM 60CAP2000-06-22
865321025702275
865321900806860
865321913964767
865321544448402
865321886116990
865321976710720

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK52020-05-04
MHX42009-03-23
CCK42006-01-12
BZK32011-06-02
CAP22000-06-22
BYE21999-03-09
DQA12004-08-26
CCL12003-03-28

PMN#

GUDID#

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