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

    NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR

    K Number: K931542 · Decision Oct 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    22
    Review Days
    210

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    Basic Information

    Device Name
    NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
    K Number
    K931542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    March 29, 1993
    Decision Date
    October 25, 1993
    Product Code
    BZK
    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
    BZK Spirometer, Monitoring (W/Wo Alarm)

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