Ikoetech, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Ikoetech, LLC makes
Ikoetech, LLC manufactures the IKOENGELO and its updated version, IKOENGELO Version 2, which are designed as medical devices for specific diagnostic or therapeutic applications in radiology or imaging procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ikoengelo, Version 2 Ref K083591
Regimes: 510(k) Registry: 510(k)Ikoengelo Ref K061006
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ikoetech, LLC have in the registry?
The registry currently lists 2 devices for Ikoetech, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ikoetech, LLC's devices?
Among its 2 most recently registered devices, Ikoetech, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Ikoetech, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ikoetech, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ikoetech, LLC in the registry?
The most recently registered devices listed for Ikoetech, LLC include IKOENGELO, VERSION 2 and IKOENGELO.