Breathesuite, Inc.
CanadaFDA 510(k) applicant, unverified
- Devices
- 1
What Breathesuite, Inc. makes
Breathesuite, Inc. manufactures the BreatheSuite MDI V1, a metered-dose inhaler designed for respiratory therapy to deliver medication directly to the lungs.
The BreatheSuite MDI V1 is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
BreatheSuite MDI V1 Ref K203155
510(k) 510(k)
Frequently asked questions
How many devices does Breathesuite, Inc. have in the registry?
The registry currently lists 1 device for Breathesuite, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breathesuite, Inc.'s devices?
Among its 1 most recently registered device, Breathesuite, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Breathesuite, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Breathesuite, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breathesuite, Inc. in the registry?
The most recently registered devices listed for Breathesuite, Inc. include BreatheSuite MDI V1.