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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
K214065
510(k) Type
Traditional
Applicant
Medtech S.A.S
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/4/2022
Days to Decision
128 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
K214065
510(k) Type
Traditional
Applicant
Medtech S.A.S
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/4/2022
Days to Decision
128 days
Submission Type
Summary