510(k) K053582 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
INQUIRY AFOCUS II DIAGNOSTIC CATHETER
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 21, 2006 |
| Received | Dec 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053582
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.