510(k) K946333 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 18, 1995 |
| Received | Dec 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946333
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.