The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa Brain.
| Device ID | K151359 |
| 510k Number | K151359 |
| Device Name: | ROSA Brain |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTECH S.A. ZAC EUREKA - 900 RUE DU MAS DE VERCHANT Montpellier, FR 34000 |
| Contact | Michael Christ |
| Correspondent | Elise Lagacherie MED TECH S.A. ZAC EUREKA - 900 RUE DU MAS DE VERCHANT Montpellier, FR 34000 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-12-18 |
| Summary: | summary |