The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Earlysense Es-16 System.
| Device ID | K070375 |
| 510k Number | K070375 |
| Device Name: | EARLYSENSE ES-16 SYSTEM |
| Classification | Monitor, Breathing Frequency |
| Applicant | EARLYSENSE LTD. 7, JABOTINSKY ST. Ramat Gan, IL 52520 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz EARLYSENSE LTD. 7, JABOTINSKY ST. Ramat Gan, IL 52520 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-11-15 |
| Summary: | summary |