Biosys Co. , Ltd. · Class II · Cleared Sep 29, 2000
| K-number | K994008 |
| Device name | BIOSYS FETAL MONITOR, MODEL IFM-500 |
| Applicant | Biosys Co. , Ltd. |
| Product code | HGM |
| Device class | Class II |
| Decision date | Sep 29, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 884.2740 |
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