510(k) K853126 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
BIO PACK MODEL 200
| Applicant | Bio Medicus, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Oct 11, 1985 |
| Received | Jul 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853126
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.