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 |
|
Date Received | 03/21/2019 |
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
|
|
|