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

    ExSpiron 2Xi

    K Number: K192595 · Decision Dec 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    ExSpiron 2Xi
    K Number
    K192595
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respiratory Motion
    Date Received
    September 20, 2019
    Decision Date
    December 17, 2019
    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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