The following data is part of a premarket notification filed by Mobilemedtek with the FDA for Electrotek.
| Device ID | K170441 |
| 510k Number | K170441 |
| Device Name: | ElectroTek |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MobileMedTek 1205 E. Washington St., Ste 115 Louisville, KY 40206 |
| Contact | Bryan Ehret |
| Correspondent | Bryan Ehret MobileMedTek 1205 E. Washington St., Ste 115 Louisville, KY 40206 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-14 |
| Decision Date | 2017-06-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ELECTROTEK 86110744 5386836 Live/Registered |
MobileMedTek Holdings, Inc. 2013-11-05 |
![]() ELECTROTEK 76014689 2519474 Live/Registered |
HORIZON GLOBAL AMERICAS INC. 2000-03-31 |