510(k) K083271

BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY by Nihon Kohden America, Inc. — Product Code MHX

K083271 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY". The FDA issued a decision of Substantially Equivalent on December 24, 2008. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.