The following data is part of a premarket notification filed by Sensible Medical Innovations Ltd. with the FDA for Reds System.
| Device ID | K180479 |
| 510k Number | K180479 |
| Device Name: | ReDS System |
| Classification | Plethysmograph, Impedance |
| Applicant | Sensible Medical Innovations Ltd. 6 Meir Areil St. Netanya, Pob 8702, IL 4059300 |
| Contact | Inbal Ben-tzvi |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2019-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110070151 | K180479 | 000 |
| 07290110070144 | K180479 | 000 |
| 07290110070267 | K180479 | 000 |
| 07290110070243 | K180479 | 000 |
| 07290110070281 | K180479 | 000 |
| 07290110070540 | K180479 | 000 |
| 07290110070328 | K180479 | 000 |