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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K012825
Device Name HEARTTRENDS
Applicant
Lev-El, Ltd.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Applicant Contact EINAT SHAMMAI
Correspondent
Lev-El, Ltd.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Correspondent Contact EINAT SHAMMAI
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/23/2001
Decision Date 03/19/2002
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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