Clearance Summary
Adhesive Electrodes received FDA 510(k) clearance under submission number K170744, sponsored by Reno Medical , 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 2017-05-08.
- Submission: K170744
- Applicant / Sponsor: Reno Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2017-05-08
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.