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

    VITALMIX (SET & BAG)

    K Number: K902482 · Decision Jul 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    VITALMIX (SET & BAG)
    K Number
    K902482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pacific Device, Inc.
    Date Received
    June 4, 1990
    Decision Date
    July 2, 1990
    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 Pacific Device, Inc.

    K Number Device Name
    K972464 VITALMIX PLUS EMPTY I.V. CONTAINER
    K923782 TRANSFER SET
    K912860 INTRAVASCULAR ADMINISTRATION SETS
    K912596 MECONIUM ASPIRATION