www.fdanews.com/articles/202388-myhomedoc-earns-510k-clearance-for-remote-examination-device
MyHomeDoc Earns 510(k) Clearance for Remote Examination Device
April 19, 2021
The FDA has given MyHomeDoc 510(k) clearance for its multi-sensor remote examination system.
The handheld device uses multiple sensors to perform remote examinations of the mouth, throat, lungs, ears, heart, skin, abdomen, body temperature and oxygen saturation (SpO2). It is now cleared for use in patients aged two years and up.
The device pairs with a user-friendly smartphone app that includes cybersecurity protections and an architecture that integrates with healthcare systems.