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

    ADD-A-VIAL

    K Number: K904855 · Decision Nov 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    13
    Review Days
    21

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    Basic Information

    Device Name
    ADD-A-VIAL
    K Number
    K904855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kendall Mcgaw Laboratories, Inc.
    Date Received
    October 29, 1990
    Decision Date
    November 19, 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 Kendall Mcgaw Laboratories, Inc.

    K Number Device Name
    K905610 MICRORATE INTELLIGENT PUMP
    K905611 MICRORATE PLUS INTELLIGENT PUMP
    K904518 VOLUMETRIC INFUSION PUMP
    K903809 PROTECTED NEEDLE WITH OR WITHOUT IV SET
    K901065 INFUSION PUMP
    K900865 ADD-A-VIAL II BINARY CONNECTOR
    K896292 1.2 MICRON FILTER WITH IV SET
    K895109 SECONDARY IV SET WITH PROTECTED NEEDLE
    K882159 522 INTELLIGENT PUMP
    K874467 SET, ADMINISTRATION INTRAVASCULAR
    Search all 13 clearances from Kendall Mcgaw Laboratories, Inc. →