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

    DISK

    K Number: K812695 · Decision Oct 13, 1981
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    DISK
    K Number
    K812695
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    American Heartline, Inc.
    Date Received
    September 22, 1981
    Decision Date
    October 13, 1981
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

    Other Clearances by American Heartline, Inc.

    K Number Device Name
    K822856 VITALINE 2