Brainscope Company, Inc.

FDA Regulatory Profile

Brainscope Company, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 11, 2019.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Known Names

brainscope company, brainscope

Recent 510(k) Clearances

K-NumberDeviceDate
K190815BrainScope TBISeptember 11, 2019
K183241BrainScope TBI (Model: Ahead 400)February 19, 2019
K181785Modified BrainScope OneDecember 19, 2018
K181179BrainScope OneMay 18, 2018
K161068Ahead 300September 22, 2016
K143643Brainscope Ahead 200May 15, 2015
DEN140025BrainScope Ahead 100November 17, 2014
K082886ZOOM-100DCAugust 10, 2009