Zelegent, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Zelegent, Inc. makes
Zelegent, Inc. makes the Elevo Snoring Intervention Set and the Elevo® Kit Snoring Intervention Device, which are designed to address snoring through oral appliance therapy.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Elevo Snoring Intervention Set Ref K213475
510(k) 510(k)Elevo® Kit Snoring Intervention Device Ref K181107
510(k) 510(k)
Frequently asked questions
How many devices does Zelegent, Inc. have in the registry?
The registry currently lists 2 devices for Zelegent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zelegent, Inc.'s devices?
Among its 2 most recently registered devices, Zelegent, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Zelegent, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Zelegent, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zelegent, Inc. in the registry?
The most recently registered devices listed for Zelegent, Inc. include Elevo Snoring Intervention Set and Elevo® Kit Snoring Intervention Device.