510(k) K001520 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
ALPHA OMEGA DUAL COOLER-HEATER
| Applicant | Alpha Omega, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | May 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001520
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.