Details
Device typeWireless patient monitor/sensor reporting software, layperson-use: A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.
FDA categoryMonitor, Orthotic/Prosthetic
Device ID00860013109806
AvailabilityOver the counter
MRI safetyMR Unsafe