Last synced on 15 September 2023 at 11:04 pm

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
K182417
510(k) Type
Traditional
Applicant
MEDTECH S.A.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
2/7/2019
Days to Decision
155 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
K182417
510(k) Type
Traditional
Applicant
MEDTECH S.A.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
2/7/2019
Days to Decision
155 days
Submission Type
Summary