BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RADIOISOTOPE CALIBRATOR (CRCO-22NB)

    K Number: K761145 · Decision Dec 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    56
    Review Days
    20

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    Basic Information

    Device Name
    RADIOISOTOPE CALIBRATOR (CRCO-22NB)
    K Number
    K761145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    November 26, 1976
    Decision Date
    December 16, 1976
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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