K250153
- 510(k) number
- K250153
- Device name
- Neu Platform
- Applicant
- Neuhealth Digital , Ltd. GB
- Product code
- GYD — Transducer, Tremor
- Decision date
- 2025-04-25
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250153.pdf
Official FDA record: K250153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.