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FDA 510(k) Applications Submitted by BrainScope Company Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K181179
05/02/2018
BrainScope One
BrainScope Company Inc.
K181785
07/03/2018
Modified BrainScope One
BrainScope Company Inc.
K183241
11/21/2018
BrainScope TBI (Model: Ahead 400)
BrainScope Company Inc.
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