510(k) K130971

OPTUM TELEHEALTH APPLICATION by Optumhealth Care Solutions, Inc. — Product Code DRG

K130971 is an FDA 510(k) premarket notification submitted by Optumhealth Care Solutions, Inc. for the device "OPTUM TELEHEALTH APPLICATION". The FDA issued a decision of Substantially Equivalent on October 23, 2013. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.