The following data is part of a premarket notification filed by Rgb Medical Devices Sa with the FDA for Tof-cuff Monitor.
| Device ID | K181894 |
| 510k Number | K181894 |
| Device Name: | TOF-Cuff Monitor |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | RGB Medical Devices SA Calle De Alfonso Gomez 42 Madrid, ES 28037 |
| Contact | Ricardo Ruiz |
| Correspondent | Ricardo Ruiz RGB Medical Devices SA Calle De Alfonso Gomez 42 Madrid, ES 28037 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2019-05-09 |