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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name audiometer
510(k) Number K112992
Model DP-GRAMMER
Device Name EARLOGIC OAE TESTER
Original Applicant
EARLOGIC CORPORATION
8 east broadway
suite 611
saly lake city,  UT  84111
Original 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
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