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

    OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

    K Number: K941919 · Decision Jun 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
    K Number
    K941919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oktas
    Date Received
    April 20, 1994
    Decision Date
    June 17, 1994
    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 Oktas

    K Number Device Name
    K970369 VISTA MINI CAMERA SYSTEM
    K970214 3 DIMENSIONAL VIDEO ENDOSCOPE
    K961182 3D SCOPE
    K946171 VIDEO ENDOSCOPE SYSTEM WITH ZOOM
    K944254 OKTAS STEREO VIEWING SYSTEM
    K944256 OKTAS INTRA-ORAL DENTAL CAMERA