# Scole Engineering Co.

- Location (FDA's records): Walker, MI
- FDA decisions: 4 (1977–1994): 4 510(k) clearances
- Product codes: DSH (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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
- Diagnostic Monitoring Software: 2 (https://510kreport.com/company/diagnostic-monitoring-software)

## Its most-cited devices
- K923664: Scole 300 Ecg Recorder (1994), cited by 2

## Recent decisions
- K923664: Scole 300 Ecg Recorder (Jan 13, 1994)
- K822362: Alta II Ecg Recorder (Jan 14, 1983)
- K822363: Alta Iii Ecg Recorder (Oct 4, 1982)
- K770829: Recording Unit, Model 1445 (May 18, 1977)

Source page: https://510kreport.com/company/scole-engineering