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 |