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Brainsway Deep (DTMS) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203616
510(k) Type
Traditional
Applicant
Brainsway Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
4/16/2021
Days to Decision
127 days
Submission Type
Summary

Brainsway Deep (DTMS) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203616
510(k) Type
Traditional
Applicant
Brainsway Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
4/16/2021
Days to Decision
127 days
Submission Type
Summary