510(k) K191394 ยท JAK System, X-Ray, Tomography, Computed
ILLUMISITE Platform
| Applicant | Covidien, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 7, 2019 |
| Received | May 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2023 | Covidien, LLC Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.