K260614
- 510(k) number
- K260614
- Device name
- Tinnitus Therapy
- Applicant
- Sivantos GmbH DE
- Product code
- KLW — Masker, Tinnitus
- Decision date
- 2026-06-10
- Date received
- 2026-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K260614.pdf
Official FDA record: K260614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.