510(k) K943458

AS/3 AIRWAY MODULE by Datex Division Instrumentarium Corp. — Product Code CBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1995
Date Received
July 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type