Device Dossier
Self-care monitoring web-based application software
Device Dossier for Self-care monitoring web-based application software (Self-care monitoring web-based application software, Class IIa, sponsor Emergo).…
- GMDN category: Self-care monitoring web-based application software
Intended purpose
The mobile application is intended for organizing and tracking blood sugar levels for individuals with diabetes mellitus and who use blood glucose monitoring devices. The mobile application does not provide specific treatment or treatment recommendations. The mobile application is a companion secondary display application. This device is not intended to replace self-monitoring practices as advised by a physician. Do not alter any treatments plans without consultation with a qualified physician. The mobile application supports diabetes management through display and analysis of information downloaded from external data sources and data input by the user. The mobile application is not intended for use by anyone unable to use mobile devices and/or computers proficiently. Users must have adequate vision in order to use the application. The mobile application does not modify data received from the CGM system, and it is not able to instruct or transmit information to the CGM system.