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

    XENON LIGHT SOURCE

    K Number: K904609 · Decision Dec 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    18
    Review Days
    68

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    Basic Information

    Device Name
    XENON LIGHT SOURCE
    K Number
    K904609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Dynamics, Inc.
    Date Received
    October 11, 1990
    Decision Date
    December 18, 1990
    Product Code
    HBI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBI Illuminator, Fiberoptic, Surgical Field

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    Other Clearances by Medical Dynamics, Inc.

    K Number Device Name
    K974542 TRUE VISION, TRUE VISION II
    K921294 VIDEO ENDOSCOPE-RIGID MODIFICATION
    K934682 SURGICAL VIDEO CAMERA AND ACCESSORIES
    K930568 ADAIR/VERESS NEEDLE INTRODUCER SET
    K915538 OVER THE WIRE STONE BASKET
    K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K911296 OPTICAL CATHETER ARTHROSCOPE
    K903339 VIDEO ENDOSCOPE, RIGID
    K904113 OPERATIVE RECORDING CAMERA
    Search all 18 clearances from Medical Dynamics, Inc. →