Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182417
ROSA ONE Brain Application · Medtech S.A · decided 2019-02-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ALPHA OMEGA MICRODRIVE HOLDER | ROSA-128E | MEDTECH | HAW | 03760244031181 |
| ROBOT ROSA ONE (USA) | 3.1.1.0 | MEDTECH | HAW OLO | 03760244032492 |
| ROSA One | 3.1.0.5 | MEDTECH | HAW | 03760244030948 |