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

    CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)

    K Number: K971584 · Decision May 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    22
    Review Days
    23

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    Basic Information

    Device Name
    CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
    K Number
    K971584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    April 30, 1997
    Decision Date
    May 23, 1997
    Product Code
    OCV
    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
    OCV Endoscope Holder

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