510(k) K982538 ยท DSP System, Balloon, Intra-Aortic And Control
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
| Applicant | Belmont Instrument Corp., Billerica MA, US |
| Decision | Substantially Equivalent, Oct 2, 1998 |
| Received | Jul 21, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982538
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.