510(k) K182112 ยท GXY Electrode, Cutaneous
Sense System with IBT Electrodes
| Applicant | Infinite Biomedical Technologies, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Aug 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182112
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.