The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Everon Central Display Station - Cds, Model Version 1.0.0.
| Device ID | K100376 |
| 510k Number | K100376 |
| Device Name: | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | EARLYSENSE LTD. 12 TZVI STREET Ramat Gan, IL 52504 |
| Contact | Dalia Argaman |
| Correspondent | Dalia Argaman EARLYSENSE LTD. 12 TZVI STREET Ramat Gan, IL 52504 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-08-06 |