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5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC

K063269 Class II Traditional
Decision Date
2007-05-23
Sponsor / Applicant
Chi Lin Technology Co., Ltd.

Technical Specification

510(k) Submission ID K063269
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2007-05-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC received FDA 510(k) clearance under submission number K063269, sponsored by Chi Lin 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 2007-05-23.

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.