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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 K190735
Device Name EQ Balance
Applicant
Upright Science, Inc.
13421 Sabal Chase
Palm Beach Gardens,  FL  33418
Applicant Contact Terry Chabrowe
Correspondent
Upright Science, Inc.
13421 Sabal Chase
Palm Beach Gardens,  FL  33418
Correspondent Contact Terry Chabrowe
Classification Product Code
LXV  
Date Received03/21/2019
Decision Date 08/16/2019
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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