K242214
- 510(k) number
- K242214
- Device name
- Sonu
- Applicant
- Sound Health Systems, Inc. CA · US
- Product code
- QZC — External Mechanical Stimulator For The Relief Of Con
- Decision date
- 2025-04-24
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242214.pdf
Official FDA record: K242214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.