The following data is part of a premarket notification filed by Phoenix Glove Co. with the FDA for Electrocardiograph Electrode.
| Device ID | K801846 |
| 510k Number | K801846 |
| Device Name: | ELECTROCARDIOGRAPH ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | PHOENIX GLOVE CO. 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 | 1980-08-04 |
| Decision Date | 1980-09-09 |