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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 K001288
Device Name DR180-II
Applicant
North East Monitoring, Inc.
730 Boston Post Rd.
Suite 23
Sudbury,  MA  01776
Applicant Contact RODNEY L CAMBRE
Correspondent
North East Monitoring, Inc.
730 Boston Post Rd.
Suite 23
Sudbury,  MA  01776
Correspondent Contact RODNEY L CAMBRE
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/24/2000
Decision Date 07/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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