The following data is part of a premarket notification filed by Compumedics Usa, Ltd. with the FDA for Conductive Eeg Electrolyte.
Device ID | K033052 |
510k Number | K033052 |
Device Name: | CONDUCTIVE EEG ELECTROLYTE |
Classification | Media, Electroconductive |
Applicant | COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso, TX 79912 |
Contact | Elvira Garcia |
Correspondent | Elvira Garcia COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso, TX 79912 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-29 |
Decision Date | 2003-12-17 |
Summary: | summary |