510(k) K092973 ยท IKT Electrode, Needle, Diagnostic Electromyograph
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
| Applicant | Bionen S.A.S., Carmel IN, US |
| Decision | Substantially Equivalent, Oct 7, 2010 |
| Received | Sep 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092973
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.