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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 K001057
Device Name AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DAVE OSBORN
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DAVE OSBORN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/03/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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