K150638 is an FDA 510(k) clearance for the AF541 SE Full Face Mask. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 18, 2015, 191 days after receiving the submission on March 11, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K150638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2015 |
| Decision Date | September 18, 2015 |
| Days to Decision | 191 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |