The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trac Eeg Electrode.
| Device ID | K950782 |
| 510k Number | K950782 |
| Device Name: | MEDI-TRAC EEG ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Contact | Ignaty Gusakov |
| Correspondent | Ignaty Gusakov GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-06-22 |