# Sound Health Systems, Inc.

- Location (FDA's records): Los Altos, CA
- FDA decisions: 2 (2023–2025): 1 510(k) clearance and 1 De Novo grant
- Product codes: QZC (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN230045: Sonu (2023), cited by 1

## Recent decisions
- K242214: Sonu (Apr 24, 2025)
- DEN230045: Sonu (Dec 4, 2023)

Source page: https://510kreport.com/company/sound-health-systems