FDA 510(k)

ACL TOP 970 CL

K 號：K233790 · 2023-12-29

決定日期2023-12-29

產品代碼JPA

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

ACL TOP 970 CL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K233790. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACL TOP 970 CL?

ACL TOP 970 CL is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Instrumentation Laboratory. The 510(k) number is K233790.

When did ACL TOP 970 CL receive FDA 510(k) clearance?

ACL TOP 970 CL received FDA 510(k) clearance on 2023-12-29, under 510(k) number K233790.

Who is the listed applicant for ACL TOP 970 CL?

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

What is the FDA product code for ACL TOP 970 CL?

The FDA product code for ACL TOP 970 CL is JPA.

相關器械（代碼：JPA）

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官方來源

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