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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K000168
Device Name CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
Applicant
Datex-Ohmeda
Three Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact JOEL KENT
Correspondent
Datex-Ohmeda
Three Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/20/2000
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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