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BrainScope TBI (Model: Ahead 400)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183241
510(k) Type
Traditional
Applicant
BrainScope Company Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/2019
Days to Decision
90 days
Submission Type
Summary

BrainScope TBI (Model: Ahead 400)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183241
510(k) Type
Traditional
Applicant
BrainScope Company Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/2019
Days to Decision
90 days
Submission Type
Summary