K101130 is an FDA 510(k) clearance for the BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK. 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 September 2, 2010, 133 days after receiving the submission on April 22, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K101130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2010 |
| Decision Date | September 02, 2010 |
| Days to Decision | 133 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 |