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 a medical device manufactured by Cryoscience North America, Inc.. It received FDA 510(k) clearance on 2022-05-25 under approval 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. It is manufactured by Cryoscience North America, Inc.. The 510(k) number is K203661.
When was CRYO Arctic, CRYO Penguin approved by the FDA?
CRYO Arctic, CRYO Penguin received FDA 510(k) clearance on 2022-05-25, under approval number K203661.
What company makes CRYO Arctic, CRYO Penguin?
CRYO Arctic, CRYO Penguin is manufactured by Cryoscience North America, Inc..
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.