The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Earlysense (everon) System.
| Device ID | K120465 |
| 510k Number | K120465 |
| Device Name: | EARLYSENSE (EVERON) SYSTEM |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-15 |
| Decision Date | 2012-06-08 |
| Summary: | summary |