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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 K001436
Device Name AGILENT M2636A TELEMON MONITOR
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DENISE HALEY
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DENISE HALEY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/08/2000
Decision Date 06/07/2000
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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