The following data is part of a premarket notification filed by Navigant Consulting, Inc. with the FDA for Electro Auricular Device.
| Device ID | K140530 |
| 510k Number | K140530 |
| Device Name: | Electro Auricular Device |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | NAVIGANT CONSULTING, INC. 30 S WACKER DRIVE SUITE 3100 Chicago, IL 60606 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle NAVIGANT CONSULTING, INC. 30 S WACKER DRIVE SUITE 3100 Chicago, IL 60606 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-10-02 |
| Summary: | summary |