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FDA 510(k)

12MP 彩色 LCD 显示器 C1216W, C12*** (* = 0 到 9, A 到 Z 或空白，不同型号之间的差异意味着产品名称根据不同的外观颜色和客户型号命名)

K号: K231026 · 2023-08-18

申请人Shenzhen Beacon Display Technology Co., Ltd.
决定日期2023-08-18
产品代码PGY
咨询委员会RA
决定实质等同

器械摘要

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Beacon Display Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231026. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)?

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Shenzhen Beacon Display Technology Co., Ltd.. The 510(k) number is K231026.

When did 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) receive FDA 510(k) clearance?

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231026.

Who is the listed applicant for 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)?

The FDA 510(k) record lists Shenzhen Beacon Display Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)?

The FDA product code for 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) is PGY.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Shenzhen Beacon Display Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252780LCD 显示器 (CL1902A, CL2103F)K253242LCD 显示器 (C1216W, C822W, C821W)K2331198MP彩色LCD显示器C811W，C811WT，PA27和PA27TK243031LCD 显示器 C310S, G310S, C316S, G316S, C616WK240310LCD 显示器 C310S, G310S, C316S, G316S, C616WK2338975MP 彩色液晶显示器/ 5MP 单色液晶显示器 (C510S，G510S，CB5MP，MB5MP，C516S，G516S)

查看所有 14 个设备 →

相关器械（代码：PGY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262783RadiForce MX247WEizo CorporationK261213医用监护仪（40HT513D）Lg Electronics.IncK252780LCD 显示器 (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD 显示器 (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo Corporation

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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