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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 K890606
Device Name OHMEDA 5330 AGENT MONITOR
Applicant
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Applicant Contact AMRIK SIKAND
Correspondent
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Correspondent Contact AMRIK SIKAND
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received02/06/1989
Decision Date 04/20/1989
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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