510(k) K011088 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SIII ALARM AMPLIFIER
| Applicant | Stockert Instrumente GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Apr 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011088
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.