510(k) K000275

DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA by Datex-Ohmeda, Inc. — Product Code CAD

K000275 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA". The FDA issued a decision of Substantially Equivalent on April 12, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2000
Date Received
January 31, 2000
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