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

    DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM

    K Number: K043344 · Decision Mar 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
    K Number
    K043344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dialysis Services, Inc.
    Date Received
    December 6, 2004
    Decision Date
    March 23, 2005
    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 Dialysis Services, Inc.

    K Number Device Name
    K060333 DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM