K183154 is an FDA 510(k) clearance for the SM Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on March 26, 2019, 132 days after receiving the submission on November 14, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K183154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2018 |
| Decision Date | March 26, 2019 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |