Respirion, Inc.
Country not established
- Devices
- 1
What Respirion, Inc. makes
Respirion, Inc. manufactures the OmniCap, a device designed for respiratory function testing and analysis, enabling precise measurement of lung mechanics and airflow dynamics in clinical and research settings.
The OmniCap 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
OmniCap Ref K171235
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Respirion, Inc. have in the registry?
The registry currently lists 1 device for Respirion, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respirion, Inc.'s devices?
Among its 1 most recently registered device, Respirion, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Respirion, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Respirion, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Respirion, Inc. in the registry?
The most recently registered devices listed for Respirion, Inc. include OmniCap.