Clearance Summary
ZMI Self-Adhesive Electrodes received FDA 510(k) clearance under submission number K180865, sponsored by Zmi Electronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-06-28.
- Submission: K180865
- Applicant / Sponsor: Zmi Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2018-06-28
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.