Beacon Biosignals, Inc.
Country not established FDA establishment FEI 3027726372
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
What Beacon Biosignals, Inc. makes
Beacon Biosignals, Inc. makes the Dreem 3S and SleepStageML devices.
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
- GUDID
- GUDID
- GUDID
Report Studio Ref K261747
510(k) 510(k)Dreem 3S Ref K242094
510(k) 510(k)Dreem 3S Ref K223539
510(k) 510(k)SleepStageML Ref K233438
510(k) 510(k)
Company details
- FDA FEI number
- 3027726372
- Address
- 22 Boston Wharf Rd Fl 7 Unit 41, Boston, MA, 02210
Frequently asked questions
How many devices does BEACON BIOSIGNALS, INC. have in the registry?
The registry currently lists 7 devices for BEACON BIOSIGNALS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BEACON BIOSIGNALS, INC.'s devices?
Among its 7 most recently registered devices, BEACON BIOSIGNALS, INC. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BEACON BIOSIGNALS, INC.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for BEACON BIOSIGNALS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BEACON BIOSIGNALS, INC. in the registry?
The most recently registered devices listed for BEACON BIOSIGNALS, INC. include IDcheck Sensor 502-0203, Waveband WB1CLMD, Waveband 3SCL1MD and Report Studio.