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

    OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES

    K Number: K862402 · Decision Feb 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    11
    Review Days
    223

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    Basic Information

    Device Name
    OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
    K Number
    K862402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medivators, Inc.
    Date Received
    June 25, 1986
    Decision Date
    February 3, 1987
    Product Code
    NVE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NVE Washer, Cleaner, Automated, Endoscope

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