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

    AQUA WATER TREATMENT FOR HEMODIALYSIS

    K Number: K010592 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    AQUA WATER TREATMENT FOR HEMODIALYSIS
    K Number
    K010592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aqua Water Treatment, Inc.
    Date Received
    February 28, 2001
    Decision Date
    September 28, 2001
    Product Code
    FIP
    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
    FIP Subsystem, Water Purification

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