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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 K944052
Device Name RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
Applicant
Ohmeda Medical
P.O. Box 7550
Madison,  WI  53707
Applicant Contact CHARLES MORREALE
Correspondent
Ohmeda Medical
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact CHARLES MORREALE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received08/19/1994
Decision Date 07/07/1995
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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