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 reduced- montage standard electroencephalograph
510(k) Number K183529
Device Name AE-120A EEG Head Set
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-ku
Tokyo,  JP 161-8560
Applicant Contact Tom Bento
Correspondent
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact Natalie Kennel
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received12/19/2018
Decision Date 03/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-