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

    VISTA HEAD MOUNTED DISPLAY

    K Number: K973436 · Decision Dec 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    VISTA HEAD MOUNTED DISPLAY
    K Number
    K973436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vista Medical Technologies, Inc.
    Date Received
    September 10, 1997
    Decision Date
    December 9, 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 Vista Medical Technologies, Inc.

    K Number Device Name
    K021290 VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
    K020301 MODIFICATION TO VISTA STEREOSCOPE SYSTEM
    K991303 VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
    K990635 VISTA STEREOSCOPE SYSTEM
    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