• 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 nystagmograph
510(k) Number K941928
Device Name VARIOUS ELECTRODES
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Applicant Contact RON ROLFSEN
Correspondent
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN,  IL  60060 -3700
Correspondent Contact RON ROLFSEN
Regulation Number882.1460
Classification Product Code
GWN  
Date Received04/20/1994
Decision Date 02/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-