CRYO Arctic, CRYO Penguin— 510(k) K203661

Substantially Equivalent

Cryoscience North America, Inc.

FDA 510(k) clearance K203661 for CRYO Arctic, CRYO Penguin, Substantially Equivalent on 2022-05-25. Applicant: Cryoscience North America, Inc.. Device class: Unclassified.

Clearance details

Applicant
Cryoscience North America, Inc.
Product code
Code MLY
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
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