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

    HEMODIALYSIS APPARATUS

    K Number: K772161 · Decision Jan 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    48

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    Basic Information

    Device Name
    HEMODIALYSIS APPARATUS
    K Number
    K772161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Heald Manufacturing, Inc.
    Date Received
    November 16, 1977
    Decision Date
    January 3, 1978
    Product Code
    FKQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FKQ System, Dialysate Delivery, Central Multiple Patient

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