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FDA 510(k) Applications Submitted by Michael E Singer
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190815
03/29/2019
BrainScope TBI
BrainScope Company, Inc.
K161068
04/15/2016
Ahead 300
BRAINSCOPE COMPANY INC
K181179
05/02/2018
BrainScope One
BrainScope Company Inc.
K181785
07/03/2018
Modified BrainScope One
BrainScope Company Inc.
K082886
09/30/2008
ZOOM-100DC
BRAINSCOPE COMPANY, INC.
K183241
11/21/2018
BrainScope TBI (Model: Ahead 400)
BrainScope Company Inc.
K143643
12/22/2014
Brainscope Ahead 200
BRAINSCOPE COMPANY, INC.
DEN140025
08/20/2014
BrainScope Ahead 100
BRAINSCOPE COMPANY, INC
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