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

    VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM

    K Number: K981827 · Decision Jul 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    10
    Review Days
    67

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    Basic Information

    Device Name
    VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    K Number
    K981827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiolaz, Inc.
    Date Received
    May 22, 1998
    Decision Date
    July 28, 1998
    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 Angiolaz, Inc.

    K Number Device Name
    K994362 HEADLAMP HL2000.
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    K982409 VES 1501-M
    K981819 ANGIOLAZ VES-1CAM
    K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K933868 ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    K913129 ANGIOLAZ ANGIOSCOPE CATHETER
    K902329 ULTRA-VU ANGIOSCOPE