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 Nystagmograph
510(k) Number K926312
Device Name INFRARED EYE MOVEMENT MONITOR
Applicant
Microguide, Inc.
14846 Shepard Dr.
Dolton,  IL  60419
Applicant Contact GLENN KROL
Correspondent
Microguide, Inc.
14846 Shepard Dr.
Dolton,  IL  60419
Correspondent Contact GLENN KROL
Regulation Number882.1460
Classification Product Code
GWN  
Date Received12/15/1992
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-