510(k) K262515
K262515 is an FDA 510(k) premarket notification submitted by Kneu Health Digital , Ltd. for the device "Kneu Platform (V2)". The FDA issued a decision of Substantially Equivalent on August 20, 2026. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2026
- Date Received
- July 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transducer, Tremor
- Device Class
- Class II
- Regulation Number
- 882.1950
- Review Panel
- NE
- Submission Type