Odi Medical AS
NorwayFDA applicant, unverified
- Devices
- 1
What Odi Medical AS makes
Odi Medical AS manufactures the ODI-Tech, a medical device designed for diagnostic or therapeutic use in a specific clinical application (device category not specified in provided data).
The ODI-Tech is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
ODI-Tech Ref K241393
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Odi Medical AS have in the registry?
The registry currently lists 1 device for Odi Medical AS. Devices recorded under merged duplicate company entries are counted once.
Which registries list Odi Medical AS's devices?
Among its 1 most recently registered device, Odi Medical AS has devices listed in FDA 510(k) (1 device).
What risk classes do Odi Medical AS's devices fall under?
Among its 1 most recently registered device, the classes recorded for Odi Medical AS's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Odi Medical AS in the registry?
The most recently registered devices listed for Odi Medical AS include ODI-Tech.