Activaero America, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Activaero America, Inc. makes
Activaero America, Inc. manufactures portable inhalation devices for respiratory therapy, including the WATCHHALER, a wearable nebulizer system, and the AKITA2 APIXNEB and AKITA JET, which are jet nebulizers designed for delivering aerosolized medication directly to the lungs.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Watchhaler Ref K080100
Regimes: 510(k) Registry: 510(k)AKITA2 Apixneb Ref K072019
Regimes: 510(k) Registry: 510(k)Akita Jet Ref K090730
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Activaero America, Inc. have in the registry?
The registry currently lists 3 devices for Activaero America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Activaero America, Inc.'s devices?
Among its 3 most recently registered devices, Activaero America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Activaero America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Activaero America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Activaero America, Inc. in the registry?
The most recently registered devices listed for Activaero America, Inc. include WATCHHALER, AKITA2 APIXNEB and AKITA JET.