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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 K070014
Device Name AUTO DETECT FOR TELAHEART DR200/E-A
Applicant
North East Monitoring, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
North East Monitoring, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number870.2800
Classification Product Code
MWJ  
Subsequent Product Code
DXH  
Date Received01/03/2007
Decision Date 05/25/2007
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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