510(k) K915333 ยท GXY Electrode, Cutaneous
ELECTRODE USING PROMEON RG-60 SERIES GEL
| Applicant | Labeltape Meditect, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Jan 14, 1992 |
| Received | Nov 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes,
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.