BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250

    K Number: K032545 · Decision Sep 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
    K Number
    K032545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mgb Endoskopische Gerate GmbH (Berlin)
    Date Received
    August 18, 2003
    Decision Date
    September 2, 2003
    Product Code
    FET
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Mgb Endoskopische Gerate GmbH (Berlin)

    K Number Device Name
    K092584 LAPORT
    K093194 MGB DISPOSABLE RETRIEVAL BAG LAPBAG
    K032544 VP-1000; MED CAM 100; VP-3000A; MED CAM 300