Breathe Technologies, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Breathe Technologies, Inc. makes
Breathe Technologies, Inc. manufactures ventilator systems and associated accessories, including the BT-V2S ventilator and a CPAP (Continuous Positive Airway Pressure) system designed for respiratory support.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where the company is based.
Catalogue
Breathe Technologies LIFE2000 Ventilation System Ref K141943
510(k) 510(k)- 510(k) 510(k)
Breathe Niov Ventilation System Ref K131562
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Breathe Technologies Ventilator And Accessories Ref K082982
510(k) 510(k)- 510(k) 510(k)
Breathe Cpap System Ref K130037
510(k) 510(k)
Frequently asked questions
How many devices does Breathe Technologies, Inc. have in the registry?
The registry currently lists 8 devices for Breathe Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breathe Technologies, Inc.'s devices?
Among its 8 most recently registered devices, Breathe Technologies, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Breathe Technologies, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Breathe Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breathe Technologies, Inc. in the registry?
The most recently registered devices listed for Breathe Technologies, Inc. include BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S, BREATHE NIOV VENTILATION SYSTEM and BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S).