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

    ENVIEW (TM)

    K Number: K102179 · Decision Dec 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    ENVIEW (TM)
    K Number
    K102179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion 2200
    Date Received
    August 3, 2010
    Decision Date
    December 2, 2010
    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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