The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Everon Central Display Station (cds).
| Device ID | K110521 |
| 510k Number | K110521 |
| Device Name: | EVERON CENTRAL DISPLAY STATION (CDS) |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | EARLYSENSE LTD. TZVI 12 Ramat-gan, IL 52504 |
| Contact | Dalia Argaman |
| Correspondent | Dalia Argaman EARLYSENSE LTD. TZVI 12 Ramat-gan, IL 52504 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-23 |
| Decision Date | 2011-04-19 |
| Summary: | summary |