BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MED-RX PATIENT DELIVERY SET

    K Number: K120375 · Decision Jun 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    143

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    Basic Information

    Device Name
    MED-RX PATIENT DELIVERY SET
    K Number
    K120375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benlan, Inc.
    Date Received
    February 6, 2012
    Decision Date
    June 28, 2012
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Benlan, Inc.

    K Number Device Name
    K131183 MED-RX ORAL/ENTERAL SYRINGE
    K112799 MED-RX EXTENSION SET WITH T-CONNECTOR
    K100700 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
    K102073 MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
    K010607 MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
    K990777 MED-RX EXTENSION SETS