Irvine Biomedical, Inc. · Class II · Cleared Jun 6, 2001
| K-number | K010471 |
| Device name | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
| Applicant | Irvine Biomedical, Inc. |
| Product code | DRF |
| Device class | Class II |
| Decision date | Jun 6, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
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