The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Em Ii Disposable Electrode.
| Device ID | K863540 |
| 510k Number | K863540 |
| Device Name: | EM II DISPOSABLE ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ELECTROMED INTL., LTD. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Megan J Macauley |
| Correspondent | Megan J Macauley 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 | 1986-09-11 |
| Decision Date | 1986-12-08 |