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

    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT

    K Number: K082988 · Decision Feb 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    56
    Applicant Total
    3
    Review Days
    129

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    Basic Information

    Device Name
    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
    K Number
    K082988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medivators Reprocessing Systems
    Date Received
    October 7, 2008
    Decision Date
    February 13, 2009
    Product Code
    FEB
    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
    FEB Accessories, Cleaning, For Endoscope

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    Other Clearances by Medivators Reprocessing Systems

    K Number Device Name
    K102996 MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
    K063876 MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING