510(k) K932389

8100 ANESTHETIC AGENT MONITOR by Biochem International, Inc. — Product Code CBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1993
Date Received
May 17, 1993
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