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

    MONITRAL S

    K Number: K861230 · Decision Apr 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    55
    Review Days
    24

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    Basic Information

    Device Name
    MONITRAL S
    K Number
    K861230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hospal Medical Corp.
    Date Received
    April 1, 1986
    Decision Date
    April 25, 1986
    Product Code
    FKP
    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
    FKP System, Dialysate Delivery, Single Patient

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    Other Clearances by Hospal Medical Corp.

    K Number Device Name
    K893742 FILTRAL TM 20 HEMODIALYZER/FILTER
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    K884326 FILTRAL TM 8 HEMODIALYZER
    K883307 CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
    K872767 FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
    K871218 MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
    K863961 HOSPAL BIOSPAL 1800S
    K863592 DISSCAP 80E, 110E, 140E, 160E
    K861156 HOSPAL DIALYSATE FOR CAVHD
    K854951 PLUME Y SET
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