510(k) K191083 ยท GXY Electrode, Cutaneous
COMPLETE CONTROL System Gen2
| Applicant | Coapt, LLC, Chicago IL, US |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Apr 24, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191083
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.