Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)— 510(k) K253055
Substantially EquivalentNordic Kinetics AB
FDA 510(k) clearance K253055 for Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW), Substantially Equivalent on 2026-06-17. Applicant: Nordic Kinetics AB. Device class: 2.
Clearance details
- Applicant
- Nordic Kinetics AB
- Product code
- Code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lund, SE
Recent devices under product code GYD
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