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 Hearing Aid, Bone Conduction
510(k) Number K110831
Device Name SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
Applicant
Sonitus Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Applicant Contact ROBERT J CHIN, PH.D.
Correspondent
Sonitus Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Correspondent Contact ROBERT J CHIN, PH.D.
Regulation Number874.3302
Classification Product Code
LXB  
Date Received03/25/2011
Decision Date 06/21/2011
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
Recalls CDRH Recalls
-
-