510(k) K091007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jul 2, 2009 |
| Received | Apr 9, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091007
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.