510(k) K051635

DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES by GE Healthcare — Product Code KOI

K051635 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 15, 2005. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. GE Healthcare has at least 10 other 510(k) clearances on record.