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 |