The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Em Electrode.
| Device ID | K853774 |
| 510k Number | K853774 |
| Device Name: | EM ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ELECTROMED INTL., LTD. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Henry Sisun |
| Correspondent | Henry Sisun ELECTROMED INTL., LTD. 34 BEAR HILL RD. Waltham, MA 02154 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-10 |
| Decision Date | 1986-04-17 |