The following data is part of a premarket notification filed by Contour Electrodes, Inc. with the FDA for Soft-e Series T-10 Accutrace Tab Resting Electrode.
| Device ID | K881085 |
| 510k Number | K881085 |
| Device Name: | SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Contact | Keith Ferrari |
| Correspondent | Keith Ferrari CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-04-11 |