Resonea, Inc.
Country not established
Resonea, Inc. is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 13 Nov 2026.
- Devices
- 2
Registry facts
- Registries
- FDA 510(k) 1
- FDA GUDID 1
- Device classes
- FDA Class II 2
- Identifiers
- DUNS 079132539
What Resonea, Inc. makes
Resonea, Inc. manufactures portable systems designed for at-home recording of sleep apnoea events, including the DROWZLE Pro and DROWZLE devices. These systems are intended for continuous monitoring of breathing patterns and sleep-related disturbances in a home setting.
The company’s products are classified as Class II medical devices and are listed under FDA 510(k) and FDA UDI registries.
Catalogue
- Regimes: 510(k) Registry: GUDID
Drowzle Ref K173974
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 079132539
Frequently asked questions
How many devices does Resonea, Inc. have in the registry?
The registry currently lists 2 devices for Resonea, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Resonea, Inc.'s devices?
Among its 2 most recently registered devices, Resonea, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Resonea, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Resonea, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Resonea, Inc. in the registry?
The most recently registered devices listed for Resonea, Inc. include DROWZLE Pro 2.0 and DROWZLE.