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

    ULTRA-VU ANGIOSCOPE

    K Number: K902329 · Decision Aug 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    ULTRA-VU ANGIOSCOPE
    K Number
    K902329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Angiolaz, Inc.
    Date Received
    May 24, 1990
    Decision Date
    August 22, 1990
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYK Angioscope

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    K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    K933868 ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    K913129 ANGIOLAZ ANGIOSCOPE CATHETER