The following data is part of a premarket notification filed by R2 Corp. with the FDA for Magnatrode Cardiac Monitoring Electrode.
| Device ID | K832516 |
| 510k Number | K832516 |
| Device Name: | MAGNATRODE CARDIAC MONITORING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | R2 CORP. 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 | 1983-07-28 |
| Decision Date | 1983-12-16 |