510(k) K000947 ยท GXY Electrode, Cutaneous
ULTRASTIM ELECTRODE, MODEL US4040
| Applicant | Axelgaard Mfg. Co., Ltd., Fallbrook CA, US |
| Decision | Substantially Equivalent, Jun 16, 2000 |
| Received | Mar 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000947
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.