510(k) K080832 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jul 30, 2008 |
| Received | Mar 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080832
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.