The following data is part of a premarket notification filed by Cortechs Labs, Inc with the FDA for Neuroquant.
Device ID | K170981 |
510k Number | K170981 |
Device Name: | NeuroQuant |
Classification | System, Image Processing, Radiological |
Applicant | CorTechs Labs, Inc 4690 Executive Drive, Suite 250 San Diego, CA 92121 |
Contact | Kora Marinkovic |
Correspondent | Kora Marinkovic CorTechs Labs, Inc 4690 Executive Drive, Suite 250 San Diego, CA 92121 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-03 |
Decision Date | 2017-09-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NEUROQUANT 77067450 3528099 Live/Registered |
CorTechs Labs, Inc 2006-12-19 |