The Vest APX System (PVAPX1)

FDA 510(k) K233441 · Baxter Healthcare Corportation

Substantially Equivalent

510(k) numberK233441

Submission

Device name
The Vest APX System (PVAPX1)
Applicant
Baxter Healthcare Corportation
Deerfield Lake, IL, US
Received
October 18, 2023
Decision date
March 22, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

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Questions and answers

When was The Vest APX System (PVAPX1) cleared by the FDA?

The Vest APX System (PVAPX1) (K233441) received a 510(k) decision of Substantially Equivalent on March 22, 2024, 156 days after the submission was received.

What is the product code of K233441?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.