510(k) K242214
- Device
- Sonu
- Applicant
- Sound Health Systems, Inc.
- 510(k) number
- K242214
- Product code
- QZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-24
- Date received
- 2024-07-29
- Regulation
- 874.6010
- Classification name
- External Mechanical Stimulator For The Relief Of Congestion
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Parameswaran Gopi
- Address
- 650b Fremont Ave. #363 Los Altos CA US 94024 94024
FDA Registration Numbers#
- 3001149827
- 3030266327
- 3008293988
Source Documents#
Other 510(k) Records For Product Code QZC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230045 | Sonu | Sound Health Systems, Inc. | 2023-12-04 |