K092043 is an FDA 510(k) clearance for the BIPAP SYNCHRONY 2. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on August 5, 2009, 30 days after receiving the submission on July 6, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K092043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2009 |
| Decision Date | August 05, 2009 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNS — Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |