Roxon - Universal Medical, Ltd.
CanadaFDA applicant, unverified
- Devices
- 1
What Roxon - Universal Medical, Ltd. makes
Roxon - Universal Medical, Ltd. manufactures the Breath-Taker Breath-Alert, a device designed to monitor and alert users to breathing patterns or respiratory events.
The Breath-Taker Breath-Alert is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Breath-Taker Breath-Alert Ref K953411
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roxon - Universal Medical, Ltd. have in the registry?
The registry currently lists 1 device for Roxon - Universal Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roxon - Universal Medical, Ltd.'s devices?
Among its 1 most recently registered device, Roxon - Universal Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Roxon - Universal Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Roxon - Universal Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roxon - Universal Medical, Ltd. in the registry?
The most recently registered devices listed for Roxon - Universal Medical, Ltd. include BREATH-TAKER BREATH-ALERT.