510(k) K861388 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SARNS PORTABLE POWER MODULE
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jun 23, 1986 |
| Received | Apr 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861388
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.