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

    DOUBLE ELUTRA-PACK UNIT

    K Number: K760914 · Decision Nov 23, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    0
    Applicant Total
    206
    Review Days
    27

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    Basic Information

    Device Name
    DOUBLE ELUTRA-PACK UNIT
    K Number
    K760914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9145
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    October 27, 1976
    Decision Date
    November 23, 1976
    Product Code
    KSW
    Advisory Committee
    Hematology
    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
    KSW System, Processing For Frozen Blood

    Other Clearances by Travenol Laboratories, S.A.

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    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871908 IV ADMINISTRATION SET
    K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
    K865029 CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
    Search all 206 clearances from Travenol Laboratories, S.A. →