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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 K061293
Device Name TELAHEART DIGITAL RECORDER
Applicant
North East Monitoring, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
North East Monitoring, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received05/09/2006
Decision Date 08/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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