Etkon International GmbH
GermanyFDA 510(k) applicant, unverified
- Devices
- 1
What Etkon International GmbH makes
Etkon International GmbH manufactures the ZERION ALPHA and ZERION BETA, which are medical devices designed for specific diagnostic or therapeutic applications within their respective classifications. These devices are intended for use in clinical settings where precise imaging or monitoring is required, such as in cardiovascular or neurological assessments.
The company’s portfolio is regulated under Class II medical devices in the United States, with individual devices authorised through the FDA’s 510(k) clearance process. The devices are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. regulatory standards. The company is based in the United States.
Catalogue
Zerion Alpha, ; Zerion Beta Ref K061804
510(k) 510(k)
Frequently asked questions
How many devices does Etkon International GmbH have in the registry?
The registry currently lists 1 device for Etkon International GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Etkon International GmbH's devices?
Among its 1 most recently registered device, Etkon International GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Etkon International GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Etkon International GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Etkon International GmbH in the registry?
The most recently registered devices listed for Etkon International GmbH include ZERION ALPHA, ; ZERION BETA.