K102985 is an FDA 510(k) clearance for the V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS. This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on April 5, 2011, 180 days after receiving the submission on October 7, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K102985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2010 |
| Decision Date | April 05, 2011 |
| Days to Decision | 180 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 |