FDA 510(k)

Vest APX 系統（PVAPX1）

K 號：K233441 · 2024-03-22

決定日期2024-03-22

產品代碼BYI

諮詢委員會AN

決定相當於

器材摘要

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

常見問題

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. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K233441.

When did The Vest APX System (PVAPX1) receive FDA 510(k) clearance?

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

Who is the listed applicant for The Vest APX System (PVAPX1)?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Baxter Healthcare Corportation 為申請人之記錄

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相關器械（代碼：BYI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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