The following data is part of a premarket notification filed by Eeg Software Llc with the FDA for Eeger4 Model 4.3.
Device ID | K122879 |
510k Number | K122879 |
Device Name: | EEGER4 MODEL 4.3 |
Classification | Device, Biofeedback |
Applicant | EEG SOFTWARE LLC 17625 MAYALL STREET Northridge, CA 91325 |
Contact | Howard Lightstone |
Correspondent | Howard Lightstone EEG SOFTWARE LLC 17625 MAYALL STREET Northridge, CA 91325 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-19 |
Decision Date | 2013-02-06 |
Summary: | summary |