The following data is part of a premarket notification filed by Rensihaw Plc with the FDA for Neuro Inspire.
| Device ID | K163666 |
| 510k Number | K163666 |
| Device Name: | Neuro Inspire |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Rensihaw Plc New Mills Wotton-under-edge, GB Gl12 8jr |
| Contact | Roberto Liddi |
| Correspondent | Roberto Liddi Rensihaw Plc New Mills Wotton-under-edge, GB Gl12 8jr |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05057078000024 | K163666 | 000 |