510(k) K223605 ยท GXY Electrode, Cutaneous
ControlSeal Electrode (ELSB)
| Applicant | Coapt, Chicago IL, US |
| Decision | Substantially Equivalent, Dec 30, 2022 |
| Received | Dec 2, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Coapt LLC Coapt ControlSeal Electrode, cutaneous EMG Electrode Open, Classified |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.