510(k) K110410

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) by Nihon Kohden Corp. — Product Code GYC

K110410 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)". The FDA issued a decision of Substantially Equivalent on August 4, 2011. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Nihon Kohden Corp. has at least 10 other 510(k) clearances on record.