510(k) K181497 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
HPM-6000UF
| Applicant | BTL Industries, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Nov 14, 2018 |
| Received | Jun 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181497
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.