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

    REPRO-MED SYSTEMS INFUSION DEVICE

    K Number: K844401 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    6
    Review Days
    119

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    Basic Information

    Device Name
    REPRO-MED SYSTEMS INFUSION DEVICE
    K Number
    K844401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Repro-Med Systems, Inc.
    Date Received
    November 13, 1984
    Decision Date
    March 12, 1985
    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 Repro-Med Systems, Inc.

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    K933652 FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
    K894299 REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
    K892529 REPRO-MED NEONATE ASPIRATION SYSTEM