The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Stealthstation Treatment Guidance Platform.
| Device ID | K003201 |
| 510k Number | K003201 |
| Device Name: | STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-12 |
| Decision Date | 2000-12-12 |