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FDA 510(k) Applications Submitted by Trudell Medical International
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150173
01/26/2015
Aerobika OPEP Devive with Manometer
Trudell Medical International
K200063
01/13/2020
AeroEclipse* ONE BAN
Trudell Medical International
K181649
06/22/2018
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Trudell Medical International
K173367
10/26/2017
MC 300* Nebulizer
Trudell Medical International
K183108
11/08/2018
Combined Aerobika OPEP and VersaPAP device
Trudell Medical International
K203400
11/19/2020
Corrugated tube with mouthpiece accessory
Trudell Medical International
K173825
12/18/2017
MC 300R* Nebulizer
Trudell Medical International
K173918
12/22/2017
VersaPAP Positive Airway Pressure (PAP) Device
Trudell Medical International
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