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 K040360
Device Name EMU128S, MODEL EX-NW-128S
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE RD.
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact CAMERON MAHON
Correspondent
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE RD.
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact CAMERON MAHON
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GYC  
Date Received02/13/2004
Decision Date 03/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-