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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 -1099
Applicant Contact DAVE OSBORN
Correspondent
AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
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
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