BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    CRYO Arctic, CRYO Penguin

    K Number: K203661 · Decision May 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    526

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    Basic Information

    Device Name
    CRYO Arctic, CRYO Penguin
    K Number
    K203661
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryoscience North America, Inc.
    Date Received
    December 15, 2020
    Decision Date
    May 25, 2022
    Product Code
    MLY
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLY Vapocoolant Device

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