BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Monitor, Lung Water Measurement

    PMA: P800003 · Supplement: S001 · Decision Jun 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Monitor, Lung Water Measurement
    Trade Name
    MODEL 9310 LUNG WATER COMPUTER
    PMA Number
    P800003
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    JEZ
    Generic Name
    MONITOR, LUNG WATER MEASUREMENT
    Regulation Number
    868.2450
    Medical Specialty
    Anesthesiology
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 12, 1981
    Date Received
    March 17, 1981
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JEZ Monitor, Lung Water Measurement