# Biosys Co., Ltd.

- Location (FDA's records): San Leandro, CA
- FDA decisions: 1 (2000–2000): 1 510(k) clearance
- Product codes: HGM (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Firms that cite its devices most
- Bistos Co., Ltd.: 2 (https://510kreport.com/company/bistos)
- Mediana Co., Ltd.: 1 (https://510kreport.com/company/mediana)

## Its most-cited devices
- K994008: Biosys Fetal Monitor, Model Ifm-500 (2000), cited by 3

## Recent decisions
- K994008: Biosys Fetal Monitor, Model Ifm-500 (Sep 29, 2000)

Source page: https://510kreport.com/company/biosys