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

    PARENTERAL INFUSER MEDIPUMP 204

    K Number: K861001 · Decision Jun 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    14
    Review Days
    86

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    Basic Information

    Device Name
    PARENTERAL INFUSER MEDIPUMP 204
    K Number
    K861001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medix Medical Electronics (U.S.A.), Inc.
    Date Received
    March 18, 1986
    Decision Date
    June 12, 1986
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Medix Medical Electronics (U.S.A.), Inc.

    K Number Device Name
    K861040 ENTERNAL INFUSER MULTIPUMP 203
    K853393 INSULIN PUMP INSUMAT 229
    K852433 INFUSAFE 205 CATOLOG NO. 205.000
    K813562 SYRINGE DRIVER 209
    K812039 SPIROMETER 210/211
    K812041 VENTI-MONITOR MODEL 101
    K812045 INFANT APNEA MONITOR MODEL 100
    K812040 OXYGEN MONITOR 140/141
    K812046 TIDAL VOLUME MONITOR 150
    K812044 RESPIRATION RATE MONITOR 120/121
    Search all 14 clearances from Medix Medical Electronics (U.S.A.), Inc. →