510(k) K160805 ยท FMI Needle, Hypodermic, Single Lumen
NIO-P
| Applicant | Waismed, Ltd., Rosh Ha'Ayin, IL |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Mar 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160805
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2016 | Waismed Ltd NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administ Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.