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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact