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 K181179
Device Name BrainScope One
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 Received05/02/2018
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-