Somnetics International, Inc. (Dba Transcend Inc)
Country not established
- Devices
- 1
What Somnetics International, Inc. (Dba Transcend Inc) makes
Somnetics International, Inc. manufactures the MySleepDash, a portable device designed for monitoring and analyzing sleep patterns in a home or clinical setting. The system captures physiological data such as heart rate, respiration, and movement to assess sleep quality and detect potential sleep disorders.
The MySleepDash is classified as a Class II medical device under FDA regulations and has undergone 510(k) clearance. The company is based in the United States.
Catalogue
MySleepDash Ref K252338
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Somnetics International, Inc. (Dba Transcend Inc) have in the registry?
The registry currently lists 1 device for Somnetics International, Inc. (Dba Transcend Inc). Devices recorded under merged duplicate company entries are counted once.
Which registries list Somnetics International, Inc. (Dba Transcend Inc)'s devices?
Among its 1 most recently registered device, Somnetics International, Inc. (Dba Transcend Inc) has devices listed in FDA 510(k) (1 device).
What risk classes do Somnetics International, Inc. (Dba Transcend Inc)'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Somnetics International, Inc. (Dba Transcend Inc)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Somnetics International, Inc. (Dba Transcend Inc) in the registry?
The most recently registered devices listed for Somnetics International, Inc. (Dba Transcend Inc) include MySleepDash.