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

    ROBERTSITE VIAL ADAPTER, MODEL 245700021

    K Number: K040634 · Decision Mar 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    ROBERTSITE VIAL ADAPTER, MODEL 245700021
    K Number
    K040634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Halkey-Roberts Corp.
    Date Received
    March 10, 2004
    Decision Date
    March 23, 2004
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Halkey-Roberts Corp.

    K Number Device Name
    K061143 ROBERTSITE STOPCOCK