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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ballistocardiograph
510(k) Number K160656
Device Name CorSens
Applicant
CorSens Medical Ltd.
3 Azrieli Center Triangular Tower 33rd Floor
132 Menachem Begin Rd.
Tel Aviv,  IL 6702301
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number870.2320
Classification Product Code
DXR  
Date Received03/08/2016
Decision Date 11/21/2016
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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