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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 K011824
Device Name AGILENT M2636B TELEMON B MONITOR (TELEMON B)
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact DENISE HALEY
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact DENISE HALEY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/11/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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