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 Full-Montage Standard Electroencephalograph
510(k) Number K192753
Device Name NeuralScan System
Applicant
Medeia, Inc.
7 W Figueroa Street, Suites 300
Santa Barbara,  CA  93101
Applicant Contact Slav Danev
Correspondent
Compliance and Regulatory Services LLC
3771 Southbrook Dr
Dayton,  OH  45430
Correspondent Contact Daniel Lehtonen
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWJ   OLT  
Date Received09/30/2019
Decision Date 03/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-