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Axonpen, Axonmonitor, Axonbox, Tablet

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201308
510(k) Type
Traditional
Applicant
ClearMind Biomedical
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/27/2020
Days to Decision
196 days
Submission Type
Summary

Axonpen, Axonmonitor, Axonbox, Tablet

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201308
510(k) Type
Traditional
Applicant
ClearMind Biomedical
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/27/2020
Days to Decision
196 days
Submission Type
Summary