510(k) K192270 ยท HIR Perineometer
LEva Pelvic Digital Health System
| Applicant | Renovia, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192270
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.