K203209 is an FDA 510(k) clearance for the AirPhysio Positive Expiratory Pressure (PEP) Device. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Airphysio Pty, Ltd. (Tweed Heads South, AU). The FDA issued a Cleared decision on January 15, 2021, 77 days after receiving the submission on October 30, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K203209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2020 |
| Decision Date | January 15, 2021 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYI - Percussor, Powered-electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |