K874735 is an FDA 510(k) clearance for the DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on January 22, 1988, 65 days after receiving the submission on November 18, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K874735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1987 |
| Decision Date | January 22, 1988 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |