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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K883532
Device Name ICOR AGENT MONITOR
Applicant
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact GEDEON, PHD
Correspondent
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact GEDEON, PHD
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received08/18/1988
Decision Date 11/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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