FDA 510(k)

The Vest APX System (PVAPX1)

K-Number: K233441 · 2024-03-22

Decision Date2024-03-22

Product CodeBYI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

The Vest APX System (PVAPX1) is a medical device manufactured by Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2024-03-22 under approval number K233441. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Vest APX System (PVAPX1)?

The Vest APX System (PVAPX1) is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Baxter Healthcare Corportation. The 510(k) number is K233441.

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

The Vest APX System (PVAPX1) received FDA 510(k) clearance on 2024-03-22, under approval number K233441.

What company makes The Vest APX System (PVAPX1)?

The Vest APX System (PVAPX1) is manufactured by Baxter Healthcare Corportation.

What is the FDA product code for The Vest APX System (PVAPX1)?

The FDA product code for The Vest APX System (PVAPX1) is BYI.

Other Devices by Baxter Healthcare Corportation

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.