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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 K133661
Device Name CHAIR SENSING UNIT FOR EARLYSENSE 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 Number868.2375
Classification Product Code
BZQ  
Subsequent Product Code
DRT  
Date Received11/29/2013
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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