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

    STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

    K Number: K023539 · Decision Dec 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW
    K Number
    K023539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valumed
    Date Received
    October 22, 2002
    Decision Date
    December 17, 2002
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Valumed

    K Number Device Name
    K023540 SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09