Irvine Biomedical, Inc. · Class II · Cleared Mar 21, 2006
| K-number | K053582 |
| Device name | INQUIRY AFOCUS II DIAGNOSTIC CATHETER |
| Applicant | Irvine Biomedical, Inc. |
| Product code | DRF |
| Device class | Class II |
| Decision date | Mar 21, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov