The following data is part of a premarket notification filed by Jordan Neuroscience, Inc. with the FDA for Ieeg.
Device ID | K131944 |
510k Number | K131944 |
Device Name: | IEEG |
Classification | Reduced- Montage Standard Electroencephalograph |
Applicant | JORDAN NEUROSCIENCE, INC. 1660 PLUM LANE Redlands, CA 92374 |
Contact | Anne Perry |
Correspondent | Anne Perry JORDAN NEUROSCIENCE, INC. 1660 PLUM LANE Redlands, CA 92374 |
Product Code | OMC |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-27 |
Decision Date | 2014-04-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IEEG 98190932 not registered Live/Pending |
Lifelines Neuro Company, LLC 2023-09-21 |