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

    PATIENT AID, MODEL DM-351

    K Number: K781176 · Decision Sep 7, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    69
    Review Days
    57

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    Basic Information

    Device Name
    PATIENT AID, MODEL DM-351
    K Number
    K781176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    July 12, 1978
    Decision Date
    September 7, 1978
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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