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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K112992
Model DP-GRAMMER
Device Name EARLOGIC OAE TESTER
Applicant
EARLOGIC CORPORATION
8 east broadway
suite 611
saly lake city,  UT  84111
Contact shin kuk yoo
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/11/2011
Decision Date 04/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-