510(k) K213913 ยท HIR Perineometer
leva Pelvic Health System
| Applicant | Renovia, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Dec 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213913
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.