# Premier Heart, LLC

- Location (FDA's records): Washington, DC
- FDA decisions: 1 (2000–2000): 1 510(k) clearance
- Product codes: DQK (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K992703: Cardiotron Ekg Multi-Phase Information Analysis System, Models 3800, 6800, 8800 (Mar 21, 2000)

Source page: https://510kreport.com/company/premier-heart