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FDA 510(k)

CRYO Arctic, CRYO Penguin

K-Number: K203661 · 2022-05-25

ApplicantCryoscience North America, Inc.
Decision Date2022-05-25
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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