FDA.reportPublic FDA data

Respironics, Inc., LA Service Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30090152093009015209Respironics, Inc., LA Service Center1N2020-04-2514101 Rosecrans Avenue, Unit F La Mirada CA US 90638

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2166661323729720K910947NEV-10 NEGATIVE PRESSURE VENTILATORBYT1991-06-03
2166662035280322K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMBYT1989-12-22
2166661669559768K870962GESCO ASPIRATORBSY1987-05-22
2166661671481864K842876PORTABLE LIFECARE VENTILATOR PLV-102CBK1984-08-29
2166661576428855K832467PORTABLE LIFECARE VENTILATOR PLV-100CBK1983-10-20
2166661707032613K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
2166661897398941K093416TRILOGY 200 VENTILATORCBK2010-01-29
2166661499939105K061261L4 OXYGEN CONCENTRATORCAW2006-06-28
2166661506477453K043615OXYTEC, MODEL 900CAW2005-02-09
2166661982445671K043006MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605CAW2005-02-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK32010-01-29
CAW32006-06-28
BYT21991-06-03
BZD12011-12-16
BSY11987-05-22