The following data is part of a premarket notification filed by Henley Intl. with the FDA for Monotrode Cutaneous Electrode.
| Device ID | K915864 |
| 510k Number | K915864 |
| Device Name: | MONOTRODE CUTANEOUS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-31 |
| Decision Date | 1993-07-21 |