510(k) K894103 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
| Applicant | Scimed Life Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 21, 1989 |
| Received | Jun 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894103
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.