510(k) K192838 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, Apr 13, 2020 |
| Received | Oct 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192838
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.