Medical Device Manufacturer · US , Alameda , CA

Breathe Technologies, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Breathe Technologies, Inc. Anesthesiology ✕
5 devices
1-5 of 5
Cleared May 17, 2013
BREATHE CPAP SYSTEM
K130037 · BZD
Anesthesiology · 130d
Cleared Feb 11, 2011
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K103345 · ONZ
Anesthesiology · 88d
Cleared Dec 02, 2010
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K102525 · ONZ
Anesthesiology · 91d
Cleared Apr 23, 2010
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
K100528 · ONZ
Anesthesiology · 58d
Cleared Jul 20, 2009
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
K082982 · ONZ
Anesthesiology · 287d
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