BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Combined Aerobika OPEP and VersaPAP device

    K Number: K183108 · Decision Aug 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    106
    Applicant Total
    9
    Review Days
    281

    Basic Information

    Device Name
    Combined Aerobika OPEP and VersaPAP device
    K Number
    K183108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trudell Medical International
    Date Received
    November 8, 2018
    Decision Date
    August 16, 2019
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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