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

    AVEA disposable expiratory filter/water trap (11790)

    K Number: K251133 · Decision May 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    AVEA disposable expiratory filter/water trap (11790)
    K Number
    K251133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Telesair, Inc.
    Date Received
    April 11, 2025
    Decision Date
    May 8, 2025
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Telesair, Inc.

    K Number Device Name
    K223863 BONHAWA Respiratory Humidifier