EQ Balance

Apparatus, Vestibular Analysis

Highmark Innovations Inc. DBA Highmark Interactive

The following data is part of a premarket notification filed by Highmark Innovations Inc. Dba Highmark Interactive with the FDA for Eq Balance.

Pre-market Notification Details

Device IDK190735
510k NumberK190735
Device Name:EQ Balance
ClassificationApparatus, Vestibular Analysis
Applicant Highmark Innovations Inc. DBA Highmark Interactive 1 University Avenue, 3rd Floor Toronto,  CA M5j 2pl
ContactDave Crane
CorrespondentE. J. Smith
Smith Associates 1468 Harwell Avenue Crofton,  MD  21114
Product CodeLXV  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-21
Decision Date2019-08-16

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