Medical Device Manufacturer · IL , Tel Aviv

Earlysense, Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2007
Official Website
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Earlysense, Ltd. Anesthesiology ✕
8 devices
1-8 of 8
Cleared Jan 04, 2018
EarlySense Bed Sensing Unit
K171836 · BZQ
Anesthesiology · 198d
Cleared May 06, 2016
EarlySense Insight Sytem
K152911 · BZQ
Anesthesiology · 217d
Cleared Jun 13, 2014
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
K133661 · BZQ
Anesthesiology · 196d
Cleared Dec 18, 2013
EARLYSENSE
K131379 · BZQ
Anesthesiology · 218d
Cleared Jun 08, 2012
EARLYSENSE (EVERON) SYSTEM
K120465 · BZQ
Anesthesiology · 114d
Cleared May 24, 2010
EVERON 1.0
K092062 · BZQ
Anesthesiology · 320d
Cleared Mar 25, 2009
EVERON
K082465 · BZQ
Anesthesiology · 210d
Cleared Nov 15, 2007
EARLYSENSE ES-16 SYSTEM
K070375 · BZQ
Anesthesiology · 280d
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