The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa Brain (v3.0.0.5).
| Device ID | K172444 |
| 510k Number | K172444 |
| Device Name: | ROSA BRAIN (v3.0.0.5) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTECH S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000 |
| Contact | Elise Lagacherie |
| Correspondent | Elise Lagacherie 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 | 2017-08-14 |
| Decision Date | 2018-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760244032799 | K172444 | 000 |
| 03760244032096 | K172444 | 000 |