510(k) K821216 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INTERPULSE MEMBRANE OXYGENATOR
| Applicant | Extracorporeal Medical Specialities, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 2, 1982 |
| Received | Apr 27, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821216
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.