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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 K000635
Device Name MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
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 Received02/25/2000
Decision Date 03/20/2000
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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