K214065 is an FDA 510(k) clearance for the ROSA ONE Brain application. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Medtech S.A.S (Mauguio, FR). The FDA issued a Cleared decision on May 4, 2022, 128 days after receiving the submission on December 27, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K214065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | May 04, 2022 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |