The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa One Brain Application.
| Device ID | K200511 |
| 510k Number | K200511 |
| Device Name: | ROSA ONE Brain Application |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtech S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000 |
| Contact | Serge Tabet |
| Correspondent | Serge Tabet Medtech 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 | 2020-03-02 |
| Decision Date | 2020-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760244033840 | K200511 | 000 |
| 03760244034403 | K200511 | 000 |
| 03760244030962 | K200511 | 000 |
| 03760244031914 | K200511 | 000 |
| 03760244032218 | K200511 | 000 |
| 03760244032294 | K200511 | 000 |
| 03760244034069 | K200511 | 000 |
| 03760244034083 | K200511 | 000 |
| 03760244034090 | K200511 | 000 |
| 03760244032119 | K200511 | 000 |
| 03760244032133 | K200511 | 000 |
| 03760244034045 | K200511 | 000 |
| 03760244034052 | K200511 | 000 |
| 03760244032195 | K200511 | 000 |