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

    IREX 730 MECHANICAL SECTOR SCANNER

    K Number: K842408 · Decision Nov 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    10
    Review Days
    163

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    Basic Information

    Device Name
    IREX 730 MECHANICAL SECTOR SCANNER
    K Number
    K842408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    June 19, 1984
    Decision Date
    November 29, 1984
    Product Code
    JAF
    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
    JAF Monitor, Ultrasonic, Nonfetal

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