K042301 is an FDA 510(k) clearance for the PROTENS ELECTRODE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on September 3, 2004, 9 days after receiving the submission on August 25, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K042301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2004 |
| Decision Date | September 03, 2004 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |