510(k) K210669 ยท DTX Gas Control Unit, Cardiopulmonary Bypass
Quantum Mini Ventilation Module
| Applicant | Spectrum Medical , Ltd., Gloucestershire, GB |
| Decision | Substantially Equivalent, May 4, 2021 |
| Received | Mar 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210669
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.