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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K121885
Device Name EARLYSENSE CENTRAL DISPLAY SYSTEM
Applicant
Earlysense, Ltd.
12 Tzvi St.
Ramat-Gan,  IL 52504
Applicant Contact DALIA ARGAMAN
Correspondent
Earlysense, Ltd.
12 Tzvi St.
Ramat-Gan,  IL 52504
Correspondent Contact DALIA ARGAMAN
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/28/2012
Decision Date 09/10/2012
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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