510(k) K071058

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A by Nihon Kohden America, Inc. — Product Code DRG

K071058 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.