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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K991831
Device Name BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
Applicant
Boston Medical Technologies, Inc.
591 N. Ave., Suite 5
Wakefield,  MA  01880
Applicant Contact DONALD BROKS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/28/1999
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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