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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K920590
Device Name OHMEDA MODEL 5250 RGM MONITOR
Applicant
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Applicant Contact KEVIN MORNINGSTAR
Correspondent
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/10/1992
Decision Date 08/31/1992
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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