The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Cutaneous Electrode.
| Device ID | K941986 |
| 510k Number | K941986 |
| Device Name: | CUTANEOUS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Contact | Ernest J Henley, Ph.d |
| Correspondent | Ernest J Henley, Ph.d MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1995-02-21 |