FDA.reportPublic FDA data

RESPIRONICS CALIFORNIA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20316423002470603RESPIRONICS CALIFORNIA, LLC1N2020-04-252271 Cosmos Ct CARLSBAD CA US 92011

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
00884838020047Philips Respironics - V60 Ventilator, English Opt: None1-800-345-6443respironics.service@philips.com
00884838020054Philips Respironics - V60 Ventilator, English,Opt: CFLEX,AVAPS1-800-345-6443respironics.service@philips.com
00884838045033PHILIPS - V60 Stand Fully Assembled+1(724)744-2500Respironics.Service@Philips.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
865291410297722K110795V200 INTELLI-TRAK OPTIONCBK2011-08-19
865291897645275K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODECBK2012-01-13
865291560212502K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSMNT2011-04-05
865291150381765K102054V200 VENTILATORCBK2010-12-22
865291937015049K082660V60 VENTILATOR, MODEL V8000MNT2009-01-09
865292022048680K053168BIPAP FOCUSMNS2006-01-04
865291523031596K034032PLV CONTINUUM VENTILATOR, MODEL P2000NOU2004-03-16
865291242668686

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK32012-01-13
MNT22011-04-05
MNS12006-01-04
NOU12004-03-16

PMN#

GUDID#