The following data is part of a premarket notification filed by Highmark Innovations Inc. Dba Highmark Interactive with the FDA for Eq Balance.
Device ID | K190735 |
510k Number | K190735 |
Device Name: | EQ Balance |
Classification | Apparatus, Vestibular Analysis |
Applicant | Highmark Innovations Inc. DBA Highmark Interactive 1 University Avenue, 3rd Floor Toronto, CA M5j 2pl |
Contact | Dave Crane |
Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
Product Code | LXV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-21 |
Decision Date | 2019-08-16 |