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

    Corrugated tube with mouthpiece accessory

    K Number: K203400 · Decision Jun 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    207

    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
    Corrugated tube with mouthpiece accessory
    K Number
    K203400
    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
    November 19, 2020
    Decision Date
    June 14, 2021
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

    Similar 510(k) Clearances

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

    FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    eRapid with eTrack System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mesh Nebulizer (H6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portable mesh nebulizer (JM821)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HeroTracker Sense

    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
    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
    K150173 Aerobika OPEP Devive with Manometer