510(k) K922876

AS/3 COP MODULE by Datex Division Instrumentarium Corp. — Product Code CBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
June 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type