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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 K171836
Device Name EarlySense Bed Sensing Unit
Applicant
EarlySense Ltd.
7 Derech Zeev Jabotinsky
Ramat Gan,  IL 5252007
Applicant Contact Dalia Argaman
Correspondent
EarlySense Ltd.
7 Derech Zeev Jabotinsky
Ramat Gan,  IL 5252007
Correspondent Contact Dalia Argaman
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/20/2017
Decision Date 01/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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