The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Graphic Controls Biotac Eco Electrode.
| Device ID | K950488 |
| 510k Number | K950488 |
| Device Name: | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET Buffalo, NY 14240 |
| Contact | Ignaty Gusakov |
| Correspondent | Ignaty Gusakov GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET Buffalo, NY 14240 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-07-03 |