Biolntellisense, Inc.
Country not established
- Devices
- 1
What Biolntellisense, Inc. makes
Biolntellisense, Inc. manufactures the BioButton System, a wearable device designed for continuous, non-invasive monitoring of physiological signals such as heart rate and activity levels.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. The BioButton System is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
BioButton System Ref K212957
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biolntellisense, Inc. have in the registry?
The registry currently lists 1 device for Biolntellisense, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolntellisense, Inc.'s devices?
Among its 1 most recently registered device, Biolntellisense, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Biolntellisense, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biolntellisense, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biolntellisense, Inc. in the registry?
The most recently registered devices listed for Biolntellisense, Inc. include BioButton System.