FDA 510(k)

Cry-Ac®，Cry-Ac-3®，Cry-Baby

K号: K193619 · 2020-03-25

决定日期2020-03-25

产品代码GEH

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决定实质等同

器械摘要

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.

常见问题

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.

相关器械（代码：GEH）

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