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 Masker, Tinnitus
510(k) Number K110973
Device Name IE-ZEN (IN CLEAR SERIES HEARING AID)
Applicant
Widex USA
2300 Cabot Dr., Suite 415
Lisle,  IL  60532
Applicant Contact FRANCIS KUK
Correspondent
Widex USA
2300 Cabot Dr., Suite 415
Lisle,  IL  60532
Correspondent Contact FRANCIS KUK
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/06/2011
Decision Date 05/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-