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2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC

K063289 Class II Traditional
Decision Date
2006-11-16
Sponsor / Applicant
Chi Lin Technology Co., Ltd.

Technical Specification

510(k) Submission ID K063289
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2006-11-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC received FDA 510(k) clearance under submission number K063289, 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 2006-11-16.

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.