BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    VOLUMETRIC INCENTIVE SPIROMETER

    K Number: K141355 · Decision Sep 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    103

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VOLUMETRIC INCENTIVE SPIROMETER
    K Number
    K141355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Besmed Health Business Corporation
    Date Received
    May 23, 2014
    Decision Date
    September 3, 2014
    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.

    InSee

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    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
    View all