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

    PHOENIX DIALYSATE METER

    K Number: K955298 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    PHOENIX DIALYSATE METER
    K Number
    K955298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Automata Medical Instrumentation, Inc.
    Date Received
    November 20, 1995
    Decision Date
    February 29, 1996
    Product Code
    FIZ
    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
    FIZ Meter, Conductivity, Non-Remote

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