510(k) K080914 ยท IKT Electrode, Needle, Diagnostic Electromyograph
ULTRASHARP CONCENTRIC NEEDLES
| Applicant | Rochester Electro Medical, Inc., Lutz FL, US |
| Decision | Substantially Equivalent, Jul 15, 2008 |
| Received | Apr 1, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K080914
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.