The Vest APX System (PVAPX1)

The Vest APX System (PVAPX1) is an FDA 510(k)-cleared medical device (K233441) manufactured by Baxter Healthcare Corportation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2024. Regulation: 8.