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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K010342
Device Name M2376A DEVICELINK SYSTEM, MODEL M2376A
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact MIKE HUDON
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact MIKE HUDON
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/05/2001
Decision Date 02/14/2001
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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