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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 K943389
Device Name SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM
Applicant
Hewlett-Packard Co.
175 Wyman St.
P.O. Box 9030
Waltham,  MS  02254
Applicant Contact RAY STELTING
Correspondent
Hewlett-Packard Co.
175 Wyman St.
P.O. Box 9030
Waltham,  MS  02254
Correspondent Contact RAY STELTING
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/14/1994
Decision Date 03/17/1995
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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