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

    PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

    K Number: K011005 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    576

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    Basic Information

    Device Name
    PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
    K Number
    K011005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pure Water Solutions, Inc.
    Date Received
    April 4, 2001
    Decision Date
    November 1, 2002
    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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    Other Clearances by Pure Water Solutions, Inc.

    K Number Device Name
    K994279 PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)