510(k) K990132

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

K990132 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC". The FDA issued a decision of Substantially Equivalent on January 21, 1999. 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.