meddevicedb.com FDA Device Reference

5MP GRAYSCALE LCD DISPLAY

K132610 Class II Traditional
Decision Date
2013-09-04
Sponsor / Applicant
Shenzhen Beacon Display Technology Co., Ltd.

Technical Specification

510(k) Submission ID K132610
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2013-09-04
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

5MP GRAYSCALE LCD DISPLAY received FDA 510(k) clearance under submission number K132610, sponsored by Shenzhen Beacon Display Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-09-04.

Classification & Regulation

This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.