The following data is part of a premarket notification filed by Advance Tech Intl. with the FDA for Pre-gelled Dispos Electrode.
| Device ID | K832877 |
| 510k Number | K832877 |
| Device Name: | PRE-GELLED DISPOS ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ADVANCE TECH INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-26 |
| Decision Date | 1983-12-22 |