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

    BICARB-O-MATE HEMODIALYSIS SOD. BICARB.

    K Number: K802465 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    35
    Review Days
    34

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    Basic Information

    Device Name
    BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
    K Number
    K802465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Renal Systems, Inc.
    Date Received
    October 9, 1980
    Decision Date
    November 12, 1980
    Product Code
    FKR
    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
    FKR Subsystem, Proportioning

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