Stephenson Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Stephenson Industries, Inc. makes
Stephenson Industries, Inc. manufactures respiratory devices, including regulator-inhalator systems and flexible collapsible chambers for inhalation therapy. The company also produces hyperbaric oxygen chambers designed for topical application, such as the Hyper Pulse Intermittent Topical Oxygen Chamber (C-100 and CB-100).
These products are classified as Class II medical devices under US regulations and are recorded in the FDA’s 510(k) clearance database. The company is based in the United States.
Catalogue
Regulator-Inhalator System Ref K853971
Regimes: 510(k) Registry: 510(k)The New Flexible Collapsible Chamber Ref K861101
Regimes: 510(k) Registry: 510(k)Topical Hyperbaric Oxygen Chamber Ref K861593
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stephenson Industries, Inc. have in the registry?
The registry currently lists 4 devices for Stephenson Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stephenson Industries, Inc.'s devices?
Among its 4 most recently registered devices, Stephenson Industries, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Stephenson Industries, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Stephenson Industries, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stephenson Industries, Inc. in the registry?
The most recently registered devices listed for Stephenson Industries, Inc. include REGULATOR-INHALATOR SYSTEM, THE NEW FLEXIBLE COLLAPSIBLE CHAMBER, TOPICAL HYPERBARIC OXYGEN CHAMBER and HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100.