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

    SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM

    K Number: K915258 · Decision Jul 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    1
    Review Days
    591

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    Basic Information

    Device Name
    SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
    K Number
    K915258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aqua-Med Systems, Inc.
    Date Received
    November 19, 1991
    Decision Date
    July 2, 1993
    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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