MyoCycle Home, MyoCycle Pro— 510(k) K170132

Substantially Equivalent

Myolyn, 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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