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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K021376
Device Name DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
Applicant
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/01/2002
Decision Date 07/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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