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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, Oxygen, Gaseous-Phase
510(k) Number K882743
Device Name OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
Applicant
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Applicant Contact VANDER WIEDE
Correspondent
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Correspondent Contact VANDER WIEDE
Regulation Number868.1720
Classification Product Code
CCL  
Date Received07/01/1988
Decision Date 08/24/1988
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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