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

    CHEMATIC BICARBONATE DIALYSATE SYSTEM

    K Number: K810605 · Decision Jun 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    58
    Review Days
    102

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    Basic Information

    Device Name
    CHEMATIC BICARBONATE DIALYSATE SYSTEM
    K Number
    K810605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Trimedyne, Inc.
    Date Received
    March 6, 1981
    Decision Date
    June 16, 1981
    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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