Company ยท IL
Earlysense, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2018. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 2018 | K171836 | EarlySense Bed Sensing Unit Earlysense, Ltd., IL | BZQ |
| May 6, 2016 | K152911 | EarlySense Insight Sytem Earlysense, Ltd., IL | BZQ |
| Aug 31, 2015 | K151006 | EarlySense Central Display Station (CDS) Earlysense, Ltd., IL | MSX |
| Jun 13, 2014 | K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM Earlysense, Ltd., IL | BZQ |
| Dec 18, 2013 | K131379 | EARLYSENSE Earlysense, Ltd., IL | BZQ |
| Sep 10, 2012 | K121885 | EARLYSENSE CENTRAL DISPLAY SYSTEM Earlysense, Ltd., IL | MSX |
| Jun 8, 2012 | K120465 | EARLYSENSE (EVERON) SYSTEM Earlysense, Ltd., IL | BZQ |
| Apr 19, 2011 | K110521 | EVERON CENTRAL DISPLAY STATION (CDS) Earlysense, Ltd., IL | MSX |
| Aug 6, 2010 | K100376 | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 Earlysense, Ltd., IL | MSX |
| May 24, 2010 | K092062 | EVERON 1.0 Earlysense, Ltd., IL | BZQ |
| Mar 25, 2009 | K082465 | EVERON Earlysense, Ltd., IL | BZQ |
| Nov 15, 2007 | K070375 | EARLYSENSE ES-16 SYSTEM Earlysense, Ltd., IL | BZQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||