510(k) K945720 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
| Applicant | Jostra Bentley, Austin TX, US |
| Decision | Substantially Equivalent, Mar 29, 1995 |
| Received | Nov 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945720
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.