BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    SMARTDOSE IV PREFILLED INFUSION CONTAINER

    K Number: K944351 · Decision Nov 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    16
    Review Days
    435

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    Basic Information

    Device Name
    SMARTDOSE IV PREFILLED INFUSION CONTAINER
    K Number
    K944351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    River Medical, Inc.
    Date Received
    September 6, 1994
    Decision Date
    November 15, 1995
    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 River Medical, Inc.

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    K943692 SMART DOSE(TM)
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    K933335 RIVER VIAL ADAPTER
    K915120 TEF/PLATINUM PISTON
    K915121 TEF/WIRE PISTON
    K913287 H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
    K913285 PTFE PISTON
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