The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Earlysense Insight Sytem.
| Device ID | K152911 |
| 510k Number | K152911 |
| Device Name: | EarlySense Insight Sytem |
| Classification | Monitor, Breathing Frequency |
| Applicant | EarlySense Ltd. 12 Tzvi Street Ramat Gan, IL 5250429 |
| Contact | Dalia Argaman |
| Correspondent | Dalia Argaman EarlySense Ltd. 12 Tzvi Street Ramat Gan, IL 5250429 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-02 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290016169109 | K152911 | 000 |
| 07290016169393 | K152911 | 000 |