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

    HydraGuard 10 UltraFilter

    K Number: K161467 · Decision Dec 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    209

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    Basic Information

    Device Name
    HydraGuard 10 UltraFilter
    K Number
    K161467
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nephros, Inc.
    Date Received
    May 27, 2016
    Decision Date
    December 22, 2016
    Product Code
    NHV
    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
    NHV System, Water Purification, General Medical Use

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