510(k) K212657 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Quantum Heater-Cooler
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Aug 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212657
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.