The following data is part of a premarket notification filed by Praxim Medivision, Sa with the FDA for Ctlogics Navigations Systems.
| Device ID | K063408 |
| 510k Number | K063408 |
| Device Name: | CTLOGICS NAVIGATIONS SYSTEMS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PRAXIM MEDIVISION, SA LE GRAND SABLON 4 AVENUE DE L'OBIOU La Tronche, FR 38700 |
| Contact | Mady Batailh |
| Correspondent | Mady Batailh PRAXIM MEDIVISION, SA LE GRAND SABLON 4 AVENUE DE L'OBIOU La Tronche, FR 38700 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-02-28 |
| Summary: | summary |