K253055
- 510(k) number
- K253055
- Device name
- Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)
- Applicant
- Nordic Kinetics AB SE
- Product code
- GYD — Transducer, Tremor
- Decision date
- 2026-06-17
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253055.pdf
Official FDA record: K253055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.