The following data is part of a premarket notification filed by Cortechs Labs, Inc. with the FDA for Deep Gray.
Device ID | K012563 |
510k Number | K012563 |
Device Name: | DEEP GRAY |
Classification | System, Image Processing, Radiological |
Applicant | CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027 |
Contact | Jeffrey M Anders |
Correspondent | Jeffrey M Anders CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-09 |
Decision Date | 2001-11-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DEEP GRAY 98207589 not registered Live/Pending |
Deep Gray LLC 2023-10-03 |
DEEP GRAY 78075298 2854898 Dead/Cancelled |
Halgren, Eric 2001-07-23 |