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

    MINNCARE HD

    K Number: K133724 · Decision Aug 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    264

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    Basic Information

    Device Name
    MINNCARE HD
    K Number
    K133724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medivators, Inc.
    Date Received
    December 6, 2013
    Decision Date
    August 27, 2014
    Product Code
    NIH
    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
    NIH Disinfectant, Subsystem, Water Purification

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