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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 K041901
Device Name SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
Applicant
NORTHEAST MONITORING, INC.
543 LONG HILL AVENUE
SHELTON,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
NORTHEAST MONITORING, INC.
543 LONG HILL AVENUE
SHELTON,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received07/14/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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