510(k) K102106

NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION by Nihon Kohden Corp. — Product Code DRG

K102106 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION". The FDA issued a decision of Substantially Equivalent on December 17, 2010. 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 Corp. has at least 10 other 510(k) clearances on record.