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

    POCKET SPIROMETER

    K Number: K830995 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    POCKET SPIROMETER
    K Number
    K830995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    P.K. Morgan Instruments, Inc.
    Date Received
    March 29, 1983
    Decision Date
    April 28, 1983
    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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