510(k) DEN230051
- Device
- Myocene
- Applicant
- Myocene
- 510(k) number
- DEN230051
- Product code
- SDX
- Decision
- Unknown (DENG)
- Decision date
- 2025-01-17
- Date received
- 2023-07-27
- Regulation
- 882.1871
- Classification name
- Neuromuscular Stimulator And Exercise Evaluation System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jean-Yves Mignolet
- Address
- Quai Banning 6 Liège BE 4000 4000
FDA Registration Numbers#
- 3036833452
Source Documents#
510(k) summary PDF not indicated by FDA