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