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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 -5810
Applicant Contact AMRIK SIKAND
Correspondent
OHMEDA MEDICAL
355 INVERNESS DR.SOUTH
ENGLEWOOD,  CO  80112 -5810
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
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