The following data is part of a premarket notification filed by Bio-scan, Inc. with the FDA for Eeg Electrodes.
Device ID | K841685 |
510k Number | K841685 |
Device Name: | EEG ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | BIO-SCAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-06-07 |