Earlysense, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: EarlySense Bed Sensing Unit
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Earlysense, Ltd. Cardiovascular ✕
4 devices
Cleared
Aug 31, 2015
EarlySense Central Display Station (CDS)
Cardiovascular
138d
Cleared
Sep 10, 2012
EARLYSENSE CENTRAL DISPLAY SYSTEM
Cardiovascular
74d
Cleared
Apr 19, 2011
EVERON CENTRAL DISPLAY STATION (CDS)
Cardiovascular
55d
Cleared
Aug 06, 2010
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
Cardiovascular
175d