FDA 510(k)

Cry-Ac®、Cry-Ac-3®、Cry-Baby

K 號：K193619 · 2020-03-25

決定日期2020-03-25

產品代碼GEH

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

Cry-Ac®, Cry-Ac-3®, Cry-Baby is the device name listed in this FDA 510(k) record. The listed applicant is Brymill Cryogenic Systems. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193619. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cry-Ac®, Cry-Ac-3®, Cry-Baby?

Cry-Ac®, Cry-Ac-3®, Cry-Baby is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Brymill Cryogenic Systems. The 510(k) number is K193619.

When did Cry-Ac®, Cry-Ac-3®, Cry-Baby receive FDA 510(k) clearance?

Cry-Ac®, Cry-Ac-3®, Cry-Baby received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193619.

Who is the listed applicant for Cry-Ac®, Cry-Ac-3®, Cry-Baby?

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

What is the FDA product code for Cry-Ac®, Cry-Ac-3®, Cry-Baby?

The FDA product code for Cry-Ac®, Cry-Ac-3®, Cry-Baby is GEH.

相關器械（代碼：GEH）

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官方來源

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