The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Eeg Electrodes.
Device ID | K962283 |
510k Number | K962283 |
Device Name: | EEG ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Contact | William H Brown |
Correspondent | William H Brown TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-13 |
Decision Date | 1996-12-16 |