K233435
- 510(k) number
- K233435
- Device name
- Peace N Quiet (0.7.0)
- Applicant
- Pnq Health MN · US
- Product code
- KLW — Masker, Tinnitus
- Decision date
- 2024-02-27
- Date received
- 2023-10-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233435.pdf
Official FDA record: K233435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.