510(k) K213768 ยท OWB Interventional Fluoroscopic X-Ray System
Bolt Navigation System
| Applicant | Circinus Medical Technology, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Dec 1, 2022 |
| Received | Dec 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213768
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.