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

    INFUSSION ALARM SYSTEM I.A.S. CAT.#1118

    K Number: K802011 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    31
    Review Days
    72

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    Basic Information

    Device Name
    INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
    K Number
    K802011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pollak (Intl.), Ltd.
    Date Received
    August 20, 1980
    Decision Date
    October 31, 1980
    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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