The following data is part of a premarket notification filed by Midwest Monitoring with the FDA for Disposable Electrode For Ekg.
| Device ID | K803179 |
| 510k Number | K803179 |
| Device Name: | DISPOSABLE ELECTRODE FOR EKG |
| Classification | Electrode, Electrocardiograph |
| Applicant | MIDWEST MONITORING 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 | 1980-12-16 |
| Decision Date | 1981-03-11 |