The following data is part of a premarket notification filed by King-devick Technologies, Inc. with the FDA for K-d Balance.
Device ID | K173669 |
510k Number | K173669 |
Device Name: | K-D Balance |
Classification | Apparatus, Vestibular Analysis |
Applicant | King-Devick Technologies, Inc. Two Mid America Plaza Suite 110 Oakbrook Terrace, IL 60181 |
Contact | Lori Grover |
Correspondent | Lori Grover King-Devick Technologies, Inc. Two Mid America Plaza Suite 110 Oakbrook Terrace, IL 60181 |
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 | 2017-11-30 |
Decision Date | 2018-04-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
K-D BALANCE 86973744 5498331 Live/Registered |
King-Devick Test, Inc. 2016-04-13 |