510(k) K190801 ยท GXZ Electrode, Needle
PressOn Electrode Headset
| Applicant | Rhythmlink International, LLC, Columbia SC, US |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190801
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.