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FDA 510(k)

CRYO Arctic, CRYO Penguin

K号: K203661 · 2022-05-25

决定日期2022-05-25
产品代码MLY
决定实质等同

器械摘要

CRYO Arctic, CRYO Penguin is the device name listed in this FDA 510(k) record. The listed applicant is Cryoscience North America, Inc.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K203661. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常见问题

What is the CRYO Arctic, CRYO Penguin?

CRYO Arctic, CRYO Penguin is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Cryoscience North America, Inc.. The 510(k) number is K203661.

When did CRYO Arctic, CRYO Penguin receive FDA 510(k) clearance?

CRYO Arctic, CRYO Penguin received FDA 510(k) clearance on 2022-05-25, under 510(k) number K203661.

Who is the listed applicant for CRYO Arctic, CRYO Penguin?

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

What is the FDA product code for CRYO Arctic, CRYO Penguin?

The FDA product code for CRYO Arctic, CRYO Penguin is MLY.

相关临床试验

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相关器械(代码:MLY)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

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