The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Earlysense Central Display Station (cds).
| Device ID | K151006 |
| 510k Number | K151006 |
| Device Name: | EarlySense Central Display Station (CDS) |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | EARLYSENSE LTD. 12 TZVI ST Ramat-gan, IL 5250429 |
| Contact | Dalia Argaman |
| Correspondent | Dalia Argaman EARLYSENSE LTD. 12 TZVI ST Ramat-gan, IL 5250429 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016169140 | K151006 | 000 |