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

    PROVIDER IV. MODEL 5000 INFUSION DEVICE

    K Number: K871806 · Decision Oct 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    10
    Review Days
    167

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    Basic Information

    Device Name
    PROVIDER IV. MODEL 5000 INFUSION DEVICE
    K Number
    K871806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pancretec, Inc.
    Date Received
    May 8, 1987
    Decision Date
    October 22, 1987
    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 Pancretec, Inc.

    K Number Device Name
    K882102 PROVIDER ONE INFUSION SYSTEM
    K844078 PROVIDER PA 3000 INFUSION SYSTEM
    K843463 PROVIDER BAG SPIKE W/12 MICROBORE EXTEN
    K841373 PROVIDER IV MODEL 2000 INFUSIN SYS
    K841017 PROVIDER INFUSION SET
    K841027 PROVIDER SITE PREP & CHECK STRIP KIT
    K833983 PROVIDER U-100 INSULIN INFUSION SYS
    K841018 PANCRETEC PUMP CHECK
    K841028 PROVIDER CAP SET