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 K122550
FOIA Releasable 510(k) K122550
Device Name ICS IMPULSE
Applicant
GN OTOMETRICS
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
GN OTOMETRICS
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.1460
Classification Product Code
GWN  
Subsequent Product Code
LXV  
Date Received08/21/2012
Decision Date 02/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-