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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 K011093
Device Name AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
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
MHX  
Date Received04/10/2001
Decision Date 05/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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