510(k) K853062 ยท DSP System, Balloon, Intra-Aortic And Control
INTRA-AORTIC BALLOON PUMP MODEL K2000
| Applicant | Kontron Instruments, Inc., Everett MA, US |
| Decision | Substantially Equivalent, Jan 22, 1986 |
| Received | Jul 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853062
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.