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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 K861397
Device Name OHMEDA 5300 ANESTHETIC AGENT MONITOR
Applicant
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Applicant Contact JULIE A REICHERT
Correspondent
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Correspondent Contact JULIE A REICHERT
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received04/15/1986
Decision Date 05/29/1986
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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