Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
510(k) Number K183241
FOIA Releasable 510(k) K183241
Device Name BrainScope TBI (Model: Ahead 400)
Applicant
BrainScope Company Inc.
4350 East West Hwy, Ste 1050
Bethesda,  MD  20814
Applicant Contact Michael E Singer
Correspondent
BrainScope Company Inc.
4350 East West Hwy, Ste 1050
Bethesda,  MD  20814
Correspondent Contact Michael E Singer
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Codes
OLU   PKQ  
Date Received11/21/2018
Decision Date 02/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-