# Digio2 International Co., Ltd.

- Location (FDA's records): Flagstaff, AZ
- FDA decisions: 3 (2009–2014): 3 510(k) clearances
- Product codes: CAF (1), FLL (1), DRG (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (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
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Kaz USA, Inc (A Subsidiaryof Kaz Inc): 1 (https://510kreport.com/company/kaz-usa-a-subsidiaryof-kaz)
- Health Hero Network, Inc.: 1 (https://510kreport.com/company/health-hero-network)

## Recent decisions
- K133105: Breeze Nebulizer (NBR-10X) (Jun 24, 2014)
- K112189: Thermo Pal Infrared Ear Thermometer (Jan 13, 2012)
- K091430: Care Pal, Model CPW-10X (Aug 21, 2009)

Source page: https://510kreport.com/company/digio2-international