Mycardio, LLC Dba Sleepimage.
United StatesFDA applicant, unverified
- Devices
- 2
What Mycardio, LLC Dba Sleepimage. makes
Mycardio, LLC Dba Sleepimage makes the SleepImage System, a medical device used for sleep monitoring and analysis.
The SleepImage System is classified as a Class II device and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
SleepImage System Ref K182618
Regimes: 510(k) Registry: 510(k)SleepImage System Ref K163696
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mycardio, LLC Dba Sleepimage. have in the registry?
The registry currently lists 2 devices for Mycardio, LLC Dba Sleepimage.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mycardio, LLC Dba Sleepimage.'s devices?
Among its 2 most recently registered devices, Mycardio, LLC Dba Sleepimage. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mycardio, LLC Dba Sleepimage.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mycardio, LLC Dba Sleepimage.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mycardio, LLC Dba Sleepimage. in the registry?
The most recently registered devices listed for Mycardio, LLC Dba Sleepimage. include SleepImage System.