510(k) K982232 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 25, 1998 |
| Received | Jun 25, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982232
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.