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

    AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

    K Number: K181649 · Decision Jan 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    203

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    Basic Information

    Device Name
    AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
    K Number
    K181649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trudell Medical International
    Date Received
    June 22, 2018
    Decision Date
    January 11, 2019
    Product Code
    NVP
    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
    NVP Holding Chambers, Direct Patient Interface

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