510(k) K901253 ยท DTZ Oxygenator, Cardiopulmonary Bypass
(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
| Applicant | Bio Medicus, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 5, 1990 |
| Received | Mar 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901253
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.