The following data is part of a premarket notification filed by Renishaw Mayfield Sarl with the FDA for Neuromate Frameless Gen Ii.
| Device ID | K132755 |
| 510k Number | K132755 |
| Device Name: | NEUROMATE FRAMELESS GEN II |
| 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 | 2013-09-03 |
| Decision Date | 2014-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662724000307 | K132755 | 000 |
| 03662724000338 | K132755 | 000 |
| 03662724000321 | K132755 | 000 |
| 03662724000314 | K132755 | 000 |
| 03662724000079 | K132755 | 000 |
| 03662724000055 | K132755 | 000 |
| 03662724000031 | K132755 | 000 |