510(k) K181942 ยท DTX Gas Control Unit, Cardiopulmonary Bypass
Quantum Ventilation Module
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, Oct 18, 2018 |
| Received | Jul 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181942
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.