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

    OPERATIVE RECORDING CAMERA

    K Number: K904113 · Decision Oct 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    18
    Review Days
    54

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    Basic Information

    Device Name
    OPERATIVE RECORDING CAMERA
    K Number
    K904113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1450
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Medical Dynamics, Inc.
    Date Received
    September 6, 1990
    Decision Date
    October 30, 1990
    Product Code
    IKO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKO Hammer, Reflex, Powered

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    K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K911296 OPTICAL CATHETER ARTHROSCOPE
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    K904609 XENON LIGHT SOURCE
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