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

    core nova Complete Operating Room Endoscopy

    K Number: K151282 · Decision Jan 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    17
    Applicant Total
    142
    Review Days
    243

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    Basic Information

    Device Name
    core nova Complete Operating Room Endoscopy
    K Number
    K151282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    May 14, 2015
    Decision Date
    January 12, 2016
    Product Code
    ODA
    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
    ODA Endoscopic Central Control Unit

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