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

    DIALYSIS MACHINES DM-346 & 346-1

    K Number: K772163 · Decision Nov 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    69
    Review Days
    12

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    Basic Information

    Device Name
    DIALYSIS MACHINES DM-346 & 346-1
    K Number
    K772163
    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
    November 16, 1977
    Decision Date
    November 28, 1977
    Product Code
    FIJ
    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
    FIJ System, Dialysate Delivery, Recirculating, Single Pass

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    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →