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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
Highmark Innovations Inc. DBA Highmark Interactive
1 University Avenue, 3rd Floor
toronto,  CA m5j 2pl
Applicant Contact dave crane
Smith Associates
1468 Harwell Avenue
crofton,  MD  21114
Correspondent Contact e. j. smith
Classification Product Code
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