The following data is part of a premarket notification filed by Encephalodynamics, Inc. with the FDA for Eeg-now.
Device ID | K180524 |
510k Number | K180524 |
Device Name: | EEG-Now |
Classification | Electrode, Cutaneous |
Applicant | EncephaloDynamics, Inc. 4320 NW 23rd Avenue, Suite 1 Gainesville, FL 32606 |
Contact | J. Chris Sackellares |
Correspondent | J. Chris Sackellares EncephaloDynamics, Inc. 4320 NW 23rd Avenue, Suite 1 Gainesville, FL 32606 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-27 |
Decision Date | 2018-05-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EEG-NOW 86170618 5176692 Live/Registered |
EncephaloDynamics, Inc. 2014-01-21 |