The following data is part of a premarket notification filed by Medtech S.a.s with the FDA for Rosa One Brain Application.
| Device ID | K214065 |
| 510k Number | K214065 |
| Device Name: | ROSA ONE Brain Application |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtech S.A.S 432 Rue Du Rajol Mauguio, FR 34130 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Medtech S.A.S 432 Rue Du Rajol Mauguio, FR 34130 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760244035127 | K214065 | 000 |
| 03760244034922 | K214065 | 000 |