510(k) K813264 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
D6ZO DISPOSABLE HEAT EXCHANGER
| Applicant | Electromedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 6, 1982 |
| Received | Nov 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813264
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.