510(k) K010471 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Feb 20, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010471
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.