The following data is part of a premarket notification filed by Respironics California, Inc. with the FDA for V60 Ventilator, Model V8000.
| Device ID | K082660 |
| 510k Number | K082660 |
| Device Name: | V60 VENTILATOR, MODEL V8000 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Contact | Mara Caler |
| Correspondent | Mara Caler RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2009-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838020054 | K082660 | 000 |
| 00884838020047 | K082660 | 000 |