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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
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