EMAY (HK) LIMITED EMO-80 EMAY

The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system. The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring. Medical Device Info. • Class II (enforcement discretion) medical device • Regulation: Oximeter, 870.2700 • Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.

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