The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Stealthstation System Goldeneye Micro-magnetic Tracking System.
| Device ID | K001284 |
| 510k Number | K001284 |
| Device Name: | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Victoria Rendon |
| Correspondent | Victoria Rendon MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2000-06-12 |