K153019 is an FDA 510(k) clearance for the Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on March 21, 2016, 158 days after receiving the submission on October 15, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K153019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2015 |
| Decision Date | March 21, 2016 |
| Days to Decision | 158 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 |