510(k) K883532

ICOR AGENT MONITOR by Icor AB — Product Code CBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1988
Date Received
August 18, 1988
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