510(k) K132530

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) by Datex-Ohmeda, Inc. — Product Code BSZ

K132530 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.