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BrainScope One

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181179
510(k) Type
Special
Applicant
BrainScope Company Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2018
Days to Decision
16 days
Submission Type
Summary

BrainScope One

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181179
510(k) Type
Special
Applicant
BrainScope Company Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2018
Days to Decision
16 days
Submission Type
Summary