510(k) K172045

Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 by Datex-Ohmeda, Inc. — Product Code BSZ

K172045 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2". The FDA issued a decision of Substantially Equivalent on November 3, 2017. 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.