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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 K002009
Device Name HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd. Ms 0491
Andover,  MA  01810
Applicant Contact MIKE HUDON
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd. Ms 0491
Andover,  MA  01810
Correspondent Contact MIKE HUDON
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/03/2000
Decision Date 08/02/2000
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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