RESPIRONICS CALIFORNIA, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2031642 | 3002470603 | RESPIRONICS CALIFORNIA, LLC | 1 | N | 2020-04-25 | 2271 Cosmos Ct CARLSBAD CA US 92011 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 86529 | 1410297722 | K110795 | V200 INTELLI-TRAK OPTION | CBK | 2011-08-19 |
| 86529 | 1897645275 | K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | CBK | 2012-01-13 |
| 86529 | 1560212502 | K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | MNT | 2011-04-05 |
| 86529 | 1150381765 | K102054 | V200 VENTILATOR | CBK | 2010-12-22 |
| 86529 | 1937015049 | K082660 | V60 VENTILATOR, MODEL V8000 | MNT | 2009-01-09 |
| 86529 | 2022048680 | K053168 | BIPAP FOCUS | MNS | 2006-01-04 |
| 86529 | 1523031596 | K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | NOU | 2004-03-16 |
| 86529 | 1242668686 |