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

    MODIFICATION TO VISTA STEREOSCOPE SYSTEM

    K Number: K020301 · Decision Feb 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO VISTA STEREOSCOPE SYSTEM
    K Number
    K020301
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vista Medical Technologies, Inc.
    Date Received
    January 29, 2002
    Decision Date
    February 12, 2002
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Vista Medical Technologies, Inc.

    K Number Device Name
    K021290 VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
    K991303 VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
    K990635 VISTA STEREOSCOPE SYSTEM
    K973436 VISTA HEAD MOUNTED DISPLAY
    K971373 VISTA SINGLE CHIP VIDEO CAMERA
    K970217 VISTA ILLUMINATION SYSTEM
    K961800 HEAD MOUNTED DISPLAY
    K953888 TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE