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

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

    K Number: K102244 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    204
    Review Days
    116

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    Basic Information

    Device Name
    RELIANCE ENDOSCOPE PROCESSING SYSTEM
    K Number
    K102244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STERIS Corporation
    Date Received
    August 9, 2010
    Decision Date
    December 3, 2010
    Product Code
    NZA
    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
    NZA Accessories, Germicide, Cleaning, For Endoscopes

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