Cardinal Health 207, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Cardinal Health 207, Inc. makes
Cardinal Health 207, Inc. manufactures respiratory support devices, including ventilators (such as the AVEA and VELA models) and gas blending systems (e.g., the Heliox Low Flow Sentry Blender). The company also produces non-vented full-face masks and nasal masks in various sizes (e.g., Puresom Nasal Mask-Small, Medium, and Large).
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Avea Ventilator Ref K081837
Regimes: 510(k) Registry: 510(k)Vela Ventilator Ref K093094
Regimes: 510(k) Registry: 510(k)Heliox Low Flow Sentry Blender Ref K092484
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardinal Health 207, Inc. have in the registry?
The registry currently lists 5 devices for Cardinal Health 207, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardinal Health 207, Inc.'s devices?
Among its 5 most recently registered devices, Cardinal Health 207, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cardinal Health 207, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cardinal Health 207, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardinal Health 207, Inc. in the registry?
The most recently registered devices listed for Cardinal Health 207, Inc. include AVEA VENTILATOR, VELA VENTILATOR, HELIOX LOW FLOW SENTRY BLENDER and THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK.