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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) Number K152911
Device Name EarlySense Insight Sytem
EarlySense Ltd.
12 Tzvi Street
Ramat Gan,  IL 5250429
Applicant Contact Dalia Argaman
EarlySense Ltd.
12 Tzvi Street
Ramat Gan,  IL 5250429
Correspondent Contact Dalia Argaman
Regulation Number868.2375
Classification Product Code
Date Received10/02/2015
Decision Date 05/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No