MyoCycle Home, MyoCycle Pro— 510(k) K170132
Substantially EquivalentMyolyn, LLC
FDA 510(k) clearance K170132 for MyoCycle Home, MyoCycle Pro, Substantially Equivalent on 2017-04-25. Applicant: Myolyn, LLC. Device class: 2.
Clearance details
- Applicant
- Myolyn, LLC
- Product code
- Code GZI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5810
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
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