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

    PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

    K Number: K994279 · Decision Dec 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    368

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    Basic Information

    Device Name
    PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
    K Number
    K994279
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pure Water Solutions, Inc.
    Date Received
    December 20, 1999
    Decision Date
    December 22, 2000
    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
    K011005 PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS