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 Stimulator, Photic, Evoked Response
510(k) Number K832084
Device Name EVOKED 3500 POTENTIAL SYSTEM
Applicant
TRACOR NORTHERN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRACOR NORTHERN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/28/1983
Decision Date 08/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-