FDA 510(k)

10PL

K 號：K220794 · 2022-11-10

決定日期2022-11-10

產品代碼ONF

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

10PL is the device name listed in this FDA 510(k) record. The listed applicant is Tentech Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220794. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 10PL?

10PL is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Tentech Co. , Ltd.. The 510(k) number is K220794.

When did 10PL receive FDA 510(k) clearance?

10PL received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220794.

Who is the listed applicant for 10PL?

The FDA 510(k) record lists Tentech Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 10PL?

The FDA product code for 10PL is ONF.

相關器械（代碼：ONF）

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官方來源

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