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Trudell Medical International

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories3
Latest FDA decision2025-01-15
TypeNumberDevice NameCodeDateActions
510(k) K242667 AeroChamber2go Anti-Static Valved Holding ChamberNVP2025-01-15 View
510(k) K203400 Corrugated tube with mouthpiece accessoryCAF2021-06-14 View
510(k) K200063 AeroEclipse* ONE BANCAF2020-07-17 View
510(k) K183108 Combined Aerobika OPEP and VersaPAP deviceBWF2019-08-16 View
510(k) K181649 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP2019-01-11 View
510(k) K173918 VersaPAP Positive Airway Pressure (PAP) DeviceBWF2018-08-17 View
510(k) K173825 MC 300R* NebulizerCAF2018-05-02 View
510(k) K173367 MC 300* NebulizerCAF2018-02-28 View
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