BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

    K Number: K874367 · Decision Jan 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    17
    Review Days
    73

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    Basic Information

    Device Name
    VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
    K Number
    K874367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Spembly Medical , Ltd.
    Date Received
    October 23, 1987
    Decision Date
    January 4, 1988
    Product Code
    HQO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQO Unit, Cautery, Thermal, Ac-Powered

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