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Earlysense, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K171836EarlySense Bed Sensing UnitJanuary 4, 2018
K152911EarlySense Insight SytemMay 6, 2016
K151006EarlySense Central Display Station (CDS)August 31, 2015
K133661CHAIR SENSING UNIT FOR EARLYSENSE SYSTEMJune 13, 2014
K131379EARLYSENSEDecember 18, 2013
K121885EARLYSENSE CENTRAL DISPLAY SYSTEMSeptember 10, 2012
K120465EARLYSENSE (EVERON) SYSTEMJune 8, 2012
K110521EVERON CENTRAL DISPLAY STATION (CDS)April 19, 2011
K100376EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0August 6, 2010
K092062EVERON 1.0May 24, 2010
K082465EVERONMarch 25, 2009
K070375EARLYSENSE ES-16 SYSTEMNovember 15, 2007