510(k) K213906 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
extriCARE 1000 Negative Pressure Wound Therapy System
| Applicant | Alleva Medical, Ltd., Shek Mun, HK |
| Decision | Substantially Equivalent, Mar 8, 2023 |
| Received | Dec 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213906
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.