Ezono AG
GermanyFDA 510(k) applicant, unverified
- Devices
- 1
What Ezono AG makes
Ezono AG manufactures the EZONO 4000, a medical device designed for use in specific diagnostic or therapeutic procedures within Class II regulatory categorization. This product is intended for applications requiring precise imaging or monitoring, such as vascular or cardiac assessments.
The EZONO 4000 is regulated under the FDA’s 510(k) pathway as a Class II device, indicating it undergoes premarket notification review. The company is based in the United States, and the device is listed in the FDA’s 510(k) registry.
Catalogue
Ezono 4000 Ref K140254
510(k) 510(k)
Frequently asked questions
How many devices does Ezono AG have in the registry?
The registry currently lists 1 device for Ezono AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ezono AG's devices?
Among its 1 most recently registered device, Ezono AG has devices listed in FDA 510(k) (1 device).
What risk classes do Ezono AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ezono AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ezono AG in the registry?
The most recently registered devices listed for Ezono AG include EZONO 4000.