510(k) K214112 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Invia Ease Negative Pressure Wound Therapy (NPWT) System
| Applicant | Medela AG, Baar, CH |
| Decision | Substantially Equivalent, Jul 26, 2022 |
| Received | Dec 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214112
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.