K121623 is an FDA 510(k) clearance for the BIPAP A 40 VENTILATORY SUPPORT SYSTEM. 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 December 14, 2012, 196 days after receiving the submission on June 1, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K121623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2012 |
| Decision Date | December 14, 2012 |
| Days to Decision | 196 days |
| Submission Type | Abbreviated |
| 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 |