510(k) K962320 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
S3 CARDIOPLEGIA CONTROL
| Applicant | Stoeckert Instrumente, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Jun 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962320
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.