# Sigma Intl. General Medical Apparatus, Inc.

- Location (FDA's records): Medina, NY
- FDA decisions: 1 (1995–1995): 1 510(k) clearance
- Product codes: FRN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (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 that cite its devices most
- Sigma Intl.: 1 (https://510kreport.com/company/sigma-intl)
- Drip Alert, Inc.: 1 (https://510kreport.com/company/drip-alert)
- Zyno Medical, LLC: 1 (https://510kreport.com/company/zyno-medical)
- Definitive Medical Technologies, Ltd.: 1 (https://510kreport.com/company/definitive-medical-technologies)

## Its most-cited devices
- K950766: Sigma 8000 and Sigma 8002 (1995), cited by 4

## Recent decisions
- K950766: Sigma 8000 and Sigma 8002 (Mar 22, 1995)

Source page: https://510kreport.com/company/sigma-intl-general-medical-apparatus