510(k) K031027

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) by Datex-Ohmeda, Inc. — Product Code CAD

K031027 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)". The FDA issued a decision of Substantially Equivalent on June 26, 2003. 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.