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 Audiometer
510(k) Number K081234
Device Name GN OTOMETRICS INSERT EARPHONES
Applicant
Gn Otometrics
125 E. Commerce Dr.
Schaumburg,  IL  60173
Applicant Contact DANIEL SANSONETTI
Correspondent
Gn Otometrics
125 E. Commerce Dr.
Schaumburg,  IL  60173
Correspondent Contact DANIEL SANSONETTI
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/01/2008
Decision Date 07/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-