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 K191868
Device Name iCEWav Neuromonitoring Platform
Applicant
iCE Neurosystems, Inc.
1875 Connecticut Ave NW, Suite 12117
Washington,  DC  20007
Applicant Contact Allen Waziri
Correspondent
EAS Consulting Group, LLC
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Allison Komiyama
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLT  
Date Received07/12/2019
Decision Date 03/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-