510(k) K231414 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
| Applicant | Chalice Medical , Ltd., Worksop, GB |
| Decision | Substantially Equivalent, Nov 1, 2023 |
| Received | May 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231414
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.