510(k) K801097 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SARNS 7000 MONITOR MODULE
| Applicant | 3M Health Care, Sarns, Mchenry IL, US |
| Decision | Substantially Equivalent, May 20, 1980 |
| Received | May 9, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801097
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.