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Electrodes with silver conductive

K171721 Class II Traditional
Decision Date
2018-01-05
Sponsor / Applicant
Shenzhen Konmed Technology Co., Ltd.

Technical Specification

510(k) Submission ID K171721
Product Code GXY
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1320
Decision Date 2018-01-05
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electrodes with silver conductive received FDA 510(k) clearance under submission number K171721, sponsored by Shenzhen Konmed Technology Co., 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 2018-01-05.

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.