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

    H.U. I.V. DROP COUNTER

    K Number: K893693 · Decision Oct 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    164

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    Basic Information

    Device Name
    H.U. I.V. DROP COUNTER
    K Number
    K893693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Li-Lien Corp.
    Date Received
    May 16, 1989
    Decision Date
    October 27, 1989
    Product Code
    FLN
    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
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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