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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 K071085
Device Name E3-80 PORTABLE ECG RECORDER & ANALYZER
Applicant
Micro-Star International Co., Ltd.
# 69, Li-De St.
Jung-He City, Taipei Hsien,  TW 235
Applicant Contact ALBUM D TSAI
Correspondent
Micro-Star International Co., Ltd.
# 69, Li-De St.
Jung-He City, Taipei Hsien,  TW 235
Correspondent Contact ALBUM D TSAI
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/17/2007
Decision Date 10/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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