510(k) K191258 ยท FMI Needle, Hypodermic, Single Lumen
Intraosseous infusion device
| Applicant | Einstein Works, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Oct 23, 2019 |
| Received | May 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191258
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.