| K-number | K925622 |
| Device name | FHB, FHB-T, FHBFLEX, FHBFLEX-T |
| Applicant | Icor AB |
| Product code | BYD |
| Device class | Class I |
| Decision date | May 26, 1993 |
| Decision | Substantially Equivalent |
| Regulation | 868.5375 |
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