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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 K010955
Device Name BMT ANSCORE HEALTH MANAGEMENT SYSTEM
Applicant
Boston Medical Technologies, Inc.
591 N. Ave., Suite 5
Wakefield,  MA  01880 -1641
Applicant Contact CESIDIO TEMPESTA
Correspondent
Boston Medical Technologies, Inc.
591 N. Ave., Suite 5
Wakefield,  MA  01880 -1641
Correspondent Contact CESIDIO TEMPESTA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/30/2001
Decision Date 04/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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