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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, With Analysis Algorithm
510(k) Number K111487
Device Name NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
Applicant
Norav Medical Corp.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Norav Medical Corp.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number870.2800
Classification Product Code
MLO  
Date Received05/31/2011
Decision Date 11/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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