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

    ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY

    K Number: K895538 · Decision Apr 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    58
    Review Days
    225

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    Basic Information

    Device Name
    ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
    K Number
    K895538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Trimedyne, Inc.
    Date Received
    September 13, 1989
    Decision Date
    April 26, 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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