Sonu
FDA 510(k) clearance K242214 · decided 2025-04-24
Clearance details
- K-number
- K242214
- Device name
- Sonu
- Applicant
- Sound Health Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-29
- Decision date
- 2025-04-24
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QZC
- Device class
- 2
- Regulation number
- 874.6010
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sonu (DEN230045) | Sound Health Systems, Inc. | 2023-12-04 |
Recalls involving this device
No recalls on record reference this clearance.