The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Lds Monitoring Electrode.
| Device ID | K821846 |
| 510k Number | K821846 |
| Device Name: | LDS MONITORING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | LIFE DESIGN SYSTEMS, INC. 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 | 1982-06-22 |
| Decision Date | 1982-07-30 |