Medical Device Manufacturer · US , Washington , DC

Brainscope Company, Inc. - FDA 510(k) Cleared Devices

8 submissions · 7 cleared · Since 2009

Recent clearances: BrainScope TBI, BrainScope TBI (Model: Ahead 400), Modified BrainScope One

8
Total
7
Cleared
1
Denied

FDA 510(k) Regulatory Record - Brainscope Company, Inc. Neurology ✕

8 devices
1-8 of 8
Cleared CT Sep 11, 2019
BrainScope TBI
K190815 · PIW
Neurology · 166d
Cleared Feb 19, 2019
BrainScope TBI (Model: Ahead 400)
K183241 · PIW
Neurology · 90d
Cleared Dec 19, 2018
Modified BrainScope One
K181785 · PIW
Neurology · 169d
Cleared May 18, 2018
BrainScope One
K181179 · PIW
Neurology · 16d
Cleared Sep 22, 2016
Ahead 300
K161068 · PIW
Neurology · 160d
Cleared May 15, 2015
Brainscope Ahead 200
K143643 · PIW
Neurology · 144d
Not Cleared Nov 17, 2014
BrainScope Ahead 100
DEN140025 · PIW
Neurology · 89d
Cleared Aug 10, 2009
ZOOM-100DC
K082886 · OLT
Neurology · 314d
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