BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUPERFLAB

    K Number: K812893 · Decision Dec 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    40
    Review Days
    54

    Basic Information

    Device Name
    SUPERFLAB
    K Number
    K812893
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1370
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    MICK RADIO-NUCLEAR INSTRUMENTS, INC.
    Date Received
    October 15, 1981
    Decision Date
    December 8, 1981
    Product Code
    IYP
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYP Phantom, Anthropomorphic, Nuclear

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