The following data is part of a premarket notification filed by Renishaw Mayfield Sarl with the FDA for Neuromate Gen Iii.
| Device ID | K180206 |
| 510k Number | K180206 |
| Device Name: | Neuromate Gen III |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Renishaw Mayfield Sarl 31, Rue Ampere Chassieu, FR 69680 |
| Contact | Stephane Vinot |
| Correspondent | Stephane Vinot Renishaw Mayfield Sarl 31, Rue Ampere Chassieu, FR 69680 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-04-24 |
| Summary: | summary |