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

    FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS

    K Number: K850208 · Decision Mar 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    31
    Review Days
    67

    Basic Information

    Device Name
    FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
    K Number
    K850208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1400
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    SYNCOR INTL. CORP.
    Date Received
    January 18, 1985
    Decision Date
    March 26, 1985
    Product Code
    IXD
    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
    IXD Source, Calibration, Sealed, Nuclear

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