The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Chair Sensing Unit For Earlysense System.
| Device ID | K133661 |
| 510k Number | K133661 |
| Device Name: | CHAIR SENSING UNIT FOR EARLYSENSE 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 | 2013-11-29 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016169065 | K133661 | 000 |