510(k) K192357 ยท QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
INNOVO
| Applicant | Atlantic Therapeutics, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Jan 16, 2020 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192357
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.