510(k) K950687 ยท DSP System, Balloon, Intra-Aortic And Control
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
| Applicant | Belmont Instrument Corp., Billerica MA, US |
| Decision | Substantially Equivalent, May 24, 1995 |
| Received | Feb 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950687
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.