510(k) K190416 ยท GXY Electrode, Cutaneous
Dome Electrode
| Applicant | Coapt, LLC, Chicago IL, US |
| Decision | Substantially Equivalent, Apr 4, 2019 |
| Received | Feb 21, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K190416
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Coapt LLC Coapt Dome Electrode, Gen2 system, cutaneous 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.