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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 K010505
Device Name TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
Applicant
Brentwood Medical Technology Corp.
3300 Fujita St.
Torrance,  CA  90505
Applicant Contact RUOMEI ZHANG
Correspondent
Brentwood Medical Technology Corp.
3300 Fujita St.
Torrance,  CA  90505
Correspondent Contact RUOMEI ZHANG
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/21/2001
Decision Date 03/09/2001
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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