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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K142424
Device Name DR300 HOLTER MONITOR
Applicant
North East Monitoring, Inc.
2 Clock Tower Pl., Suite 555
Maynard,  MA  01754
Applicant Contact SHERRY STEELE
Correspondent
North East Monitoring, Inc.
2 Clock Tower Pl., Suite 555
Maynard,  MA  01754
Correspondent Contact SHERRY STEELE
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received08/29/2014
Decision Date 11/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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