510(k) K140780 ยท HIR Perineometer
KEGEL SMART, KEGELSMART PEARL
| Applicant | Regulatory Insight, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Sep 10, 2014 |
| Received | Mar 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140780
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.