K180865 is an FDA 510(k) clearance for the ZMI Self-Adhesive Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Zmi Electronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on June 28, 2018, 87 days after receiving the submission on April 2, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K180865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2018 |
| Decision Date | June 28, 2018 |
| Days to Decision | 87 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 |