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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K173669
Device Name K-D Balance
Applicant
King-Devick Technologies, Inc.
Two Mid America Plaza, Suite 110
Oakbrook Terrace,  IL  60181
Applicant Contact Lori Grover
Correspondent
King-Devick Technologies, Inc.
Two Mid America Plaza, Suite 110
Oakbrook Terrace,  IL  60181
Correspondent Contact Lori Grover
Classification Product Code
LXV  
Date Received11/30/2017
Decision Date 04/02/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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