Stanley Aviation Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Stanley Aviation Corp. makes
Stanley Aviation Corp. manufactures medical oxygen concentrators, including the Model 379 WXYGEN Concentrator, which delivers oxygen therapy for patients at home. They also produce the Model 381 Home Oxygen Sentry, a device designed to monitor and alert for oxygen supply issues in residential settings.
The company’s products are regulated as Class II devices under the FDA’s 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Model 379 Wxygen Concentrator Ref K801523
Regimes: 510(k) Registry: 510(k)Model 381 Home Oxygen Sentry Ref K811702
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stanley Aviation Corp. have in the registry?
The registry currently lists 2 devices for Stanley Aviation Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stanley Aviation Corp.'s devices?
Among its 2 most recently registered devices, Stanley Aviation Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Stanley Aviation Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stanley Aviation Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stanley Aviation Corp. in the registry?
The most recently registered devices listed for Stanley Aviation Corp. include MODEL 379 WXYGEN CONCENTRATOR and MODEL 381 HOME OXYGEN SENTRY.