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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451003447 | K033052 | 000 |
| 09342451003430 | K033052 | 000 |
| 09342451003423 | K033052 | 000 |
| 09342451003416 | K033052 | 000 |