FDA 510(k)

VIO 系統（V-1000）

K 號：K232789 · 2023-12-22

決定日期2023-12-22

產品代碼QZN

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VIO System (V-1000) is the device name listed in this FDA 510(k) record. The listed applicant is Enspectra Health, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232789. The device is classified under product code QZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VIO System (V-1000)?

VIO System (V-1000) is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Enspectra Health, Inc.. The 510(k) number is K232789.

When did VIO System (V-1000) receive FDA 510(k) clearance?

VIO System (V-1000) received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232789.

Who is the listed applicant for VIO System (V-1000)?

The FDA 510(k) record lists Enspectra Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIO System (V-1000)?

The FDA product code for VIO System (V-1000) is QZN.

官方來源

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器材摘要

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