K082660 is an FDA 510(k) clearance for the V60 VENTILATOR, MODEL V8000. This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Respironics California, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 9, 2009, 119 days after receiving the submission on September 12, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K082660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2008 |
| Decision Date | January 09, 2009 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |