510(k) K912283 ยท IKT Electrode, Needle, Diagnostic Electromyograph
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
| Applicant | Chalgren Enterprises, Inc., Gilroy CA, US |
| Decision | Substantially Equivalent, Mar 16, 1992 |
| Received | May 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Chalgren Enterprises Inc Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA. Terminated |
IKT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.