510(k) K892878 ยท DSP System, Balloon, Intra-Aortic And Control
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
| Applicant | Kontron Instruments, Inc., Everett MA, US |
| Decision | Substantially Equivalent, Sep 13, 1989 |
| Received | Apr 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892878
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.