K233441 is an FDA 510(k) clearance for the The Vest APX System (PVAPX1). This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Baxter Healthcare Corportation (Deerfield Lake, US). The FDA issued a Cleared decision on March 22, 2024, 156 days after receiving the submission on October 18, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K233441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 156 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 |