510(k) K191597 ยท HAW Neurological Stereotaxic Instrument
Stealth Autoguide System, Midas Rex Legend Depth Stop System
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Nov 1, 2019 |
| Received | Jun 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2021 | Medtronic Navigation, Inc. Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit. Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.