510(k) K031027

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2003
Date Received
April 1, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type