Medical Device Manufacturer · US , Washington , DC

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

8 submissions · 7 cleared · Since 2009

8

Total

7

Cleared

1

Denied

FDA 510(k) cleared devices by Brainscope Company, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Sep 11, 2019

Neurology · 166d

Cleared Feb 19, 2019

BrainScope TBI (Model: Ahead 400)

Neurology · 90d

Cleared Dec 19, 2018

Modified BrainScope One

Neurology · 169d

Cleared May 18, 2018

Neurology · 16d

Cleared Sep 22, 2016

Neurology · 160d

Cleared May 15, 2015

Brainscope Ahead 200

Neurology · 144d

Not Cleared Nov 17, 2014

BrainScope Ahead 100

DEN140025 · PIW

Neurology · 89d

Cleared Aug 10, 2009

Neurology · 314d