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

    PORTABLE ENDOSCOPY SYSTEM

    K Number: K950712 · Decision May 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    17
    Applicant Total
    4
    Review Days
    455

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    Basic Information

    Device Name
    PORTABLE ENDOSCOPY SYSTEM
    K Number
    K950712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laser-Optik-Systeme GmbH & Co. KG
    Date Received
    February 14, 1995
    Decision Date
    May 14, 1996
    Product Code
    GCM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCM Endoscope, Rigid

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    Other Clearances by Laser-Optik-Systeme GmbH & Co. KG

    K Number Device Name
    K972056 STANDARD ENDOSCOPE
    K952028 COLD LIGHT SOURCE LOS XL-A 100
    K951829 COLD LIGHT SOURCE LOS 150