510(k) K964869

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR by The Magstim Company , Ltd. — Product Code ETN

K964869 is an FDA 510(k) premarket notification submitted by The Magstim Company , Ltd. for the device "NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR". The FDA issued a decision of Substantially Equivalent on May 14, 1997. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. The Magstim Company , Ltd. has at least 10 other 510(k) clearances on record.