FDA Product Code
FDA Product Code QZC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.6010
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242214 | Sonu | Sound Health Systems, Inc. | 2025-04-24 | Traditional | PDF ↗ |
| DEN230045 | Sonu | Sound Health Systems, Inc. | 2023-12-04 | Direct | — |
Product code QZC · Class II · Ear, Nose, Throat. Data: openFDA.