Isonea, Ltd.
Country not established
- Devices
- 1
What Isonea, Ltd. makes
Isonea, Ltd. manufactures the SONOSENTRY, a medical device designed for ultrasound-based monitoring or imaging applications, though specific clinical use is not detailed.
The SONOSENTRY is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Sonosentry Ref K131285
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isonea, Ltd. have in the registry?
The registry currently lists 1 device for Isonea, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isonea, Ltd.'s devices?
Among its 1 most recently registered device, Isonea, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Isonea, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Isonea, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isonea, Ltd. in the registry?
The most recently registered devices listed for Isonea, Ltd. include SONOSENTRY.