K262515
- 510(k) number
- K262515
- Device name
- Kneu Platform (V2)
- Applicant
- Kneu Health Digital , Ltd. GB
- Product code
- GYD — Transducer, Tremor
- Decision date
- 2026-08-20
- Date received
- 2026-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K262515.pdf
Official FDA record: K262515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.