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

    RESPIRATION MONITOR

    K Number: K832999 · Decision Feb 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    38
    Review Days
    179

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    Basic Information

    Device Name
    RESPIRATION MONITOR
    K Number
    K832999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Medical Electronics
    Date Received
    August 18, 1983
    Decision Date
    February 13, 1984
    Product Code
    FLS
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLS Monitor, Apnea, Facility Use

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