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MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213925
510(k) Type
Traditional
Applicant
Myolyn, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2022
Days to Decision
130 days
Submission Type
Summary

MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213925
510(k) Type
Traditional
Applicant
Myolyn, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2022
Days to Decision
130 days
Submission Type
Summary