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

    HIMOBILIX 2N

    K Number: K883161 · Decision Oct 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    HIMOBILIX 2N
    K Number
    K883161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Bay X-Ray, Inc.
    Date Received
    July 26, 1988
    Decision Date
    October 21, 1988
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Bay X-Ray, Inc.

    K Number Device Name
    K883160 CATAPULT BUCKY (KATAPULT BLENDA)
    K883155 RASTIX X-RAY TABLE
    K883162 TELESTATIX X-RAY TABLE
    K883153 UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
    K883154 SELDIX 325 TWO PULSE GENERATOR/CONTROL