510(k) K260453 ยท GXY Electrode, Cutaneous
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
| Applicant | Bionit Labs Srl, Soleto, IT |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Feb 11, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260453
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.