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

    CARDIAC PROBE

    K Number: K760595 · Decision Sep 17, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    29
    Applicant Total
    56
    Review Days
    10

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    Basic Information

    Device Name
    CARDIAC PROBE
    K Number
    K760595
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1320
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    September 7, 1976
    Decision Date
    September 17, 1976
    Product Code
    IZD
    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
    IZD Probe, Uptake, Nuclear

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