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ROSA ONE Brain Application

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231103
510(k) Type
Traditional
Applicant
Medtech S.A.S
Country
France
FDA Decision
Substantially Equivalent
Decision Date
7/20/2023
Days to Decision
92 days
Submission Type
Summary

ROSA ONE Brain Application

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231103
510(k) Type
Traditional
Applicant
Medtech S.A.S
Country
France
FDA Decision
Substantially Equivalent
Decision Date
7/20/2023
Days to Decision
92 days
Submission Type
Summary