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

    AMICON EQUALINE FLUID BALANCE SYSTEM

    K Number: K875121 · Decision Feb 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    20
    Review Days
    66

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    Basic Information

    Device Name
    AMICON EQUALINE FLUID BALANCE SYSTEM
    K Number
    K875121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Amicon, Inc.
    Date Received
    December 15, 1987
    Decision Date
    February 19, 1988
    Product Code
    KPF
    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
    KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal

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