510(k) K240915 ยท FMI Needle, Hypodermic, Single Lumen
ZIEN IO Intraosseous Access System
| Applicant | Zien Medical Technologies, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 2, 2024 |
| Received | Apr 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240915
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.