DEN230051
- 510(k) number
- DEN230051
- Device name
- Myocene
- Applicant
- Myocene BE
- Product code
- SDX — Neuromuscular Stimulator And Exercise Evaluation Sys
- Decision date
- 2025-01-17
- Date received
- 2023-07-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN230051
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.