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

    3-CCD DIGITAL CAMERA

    K Number: K970605 · Decision May 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    93

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    Basic Information

    Device Name
    3-CCD DIGITAL CAMERA
    K Number
    K970605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Envision Medical Corp.
    Date Received
    February 18, 1997
    Decision Date
    May 22, 1997
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Envision Medical Corp.

    K Number Device Name
    K953438 SURGICAL INTEGRATED CAMERA SYSTEM
    K951971 XENON LIGHT SOURCE
    K944707 ISOLATED CAMERA HEAD
    K934092 CAMERA, SURGICAL AND ACCESSORIES