ELECTROFLEX
Device Facts
| Record ID | K943126 |
|---|---|
| Device Name | ELECTROFLEX |
| Applicant | Medical Devices, Inc. |
| Product Code | GXY · Neurology |
| Decision Date | Dec 5, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
