510(k) K002878

DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER by Datex-Ohmeda, Inc. — Product Code CAD

K002878 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER". The FDA issued a decision of Substantially Equivalent on September 21, 2000. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.