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. Cardiovascular ✕

4 devices

1-4 of 4

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