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

    Aerobika OPEP Devive with Manometer

    K Number: K150173 · Decision Oct 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    106
    Applicant Total
    9
    Review Days
    262

    Basic Information

    Device Name
    Aerobika OPEP Devive with Manometer
    K Number
    K150173
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trudell Medical International
    Date Received
    January 26, 2015
    Decision Date
    October 15, 2015
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BWF), ordered by most recent decision date.

    AllPEP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LungTrainer (MD2 & MD3)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Breathe+

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI Triflo II Incentive Deep Breathing Exerciser

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pulsehaler

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    D R Burton OxyPAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Trudell Medical International

    K Number Device Name
    K242667 AeroChamber2go Anti-Static Valved Holding Chamber
    K203400 Corrugated tube with mouthpiece accessory
    K200063 AeroEclipse* ONE BAN
    K183108 Combined Aerobika OPEP and VersaPAP device
    K181649 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
    K173918 VersaPAP Positive Airway Pressure (PAP) Device
    K173825 MC 300R* Nebulizer
    K173367 MC 300* Nebulizer