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

    RESPIRATOR MONITOR

    K Number: K813198 · Decision Dec 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    119
    Applicant Total
    2
    Review Days
    25

    Basic Information

    Device Name
    RESPIRATOR MONITOR
    K Number
    K813198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    FLORIDA MEDICAL EQUIPMENT REPAIR, INC.
    Date Received
    November 13, 1981
    Decision Date
    December 8, 1981
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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