FDA 510(k)

LCD 螢幕（C1216W、C822W、C821W）

K 號：K253242 · 2025-10-29

申請人Shenzhen Beacon Display Technology Co., Ltd.

決定日期2025-10-29

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

LCD Monitor (C1216W, C822W, C821W) 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 2025-10-29 under 510(k) number K253242. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LCD Monitor (C1216W, C822W, C821W)?

LCD Monitor (C1216W, C822W, C821W) is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Shenzhen Beacon Display Technology Co., Ltd.. The 510(k) number is K253242.

When did LCD Monitor (C1216W, C822W, C821W) receive FDA 510(k) clearance?

LCD Monitor (C1216W, C822W, C821W) received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253242.

Who is the listed applicant for LCD Monitor (C1216W, C822W, C821W)?

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 LCD Monitor (C1216W, C822W, C821W)?

The FDA product code for LCD Monitor (C1216W, C822W, C821W) is PGY.

其他以 Shenzhen Beacon Display Technology Co., Ltd. 為申請人之記錄

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K252780LCD 螢幕（CL1902A，CL2103F）K2331198MP 彩色 LCD 屏幕C811W, C811WT, PA27 和 PA27T K243031LCD 螢幕 C310S、G310S、C316S、G316S、C616W K240310LCD 螢幕 C310S、G310S、C316S、G316S、C616W K2338975MP 彩色 LCD 监视器/ 5MP 单色 LCD 监视器（C510S，G510S，CB5MP，MB5MP，C516S，G516S）K23102612MP 彩色 LCD 監視器 C1216W, C12*** (* = 0 至 9, A 至 Z 或空白，不同型號之間的差異意味著產品的名稱是根據不同的外觀顏色和客戶型號命名的)

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相關器械（代碼：PGY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262783麥迪克斯 MX247WEizo Corporation K261213醫療監視器（40HT513D）Lg Electronics.Inc K252780LCD 螢幕（CL1902A，CL2103F）Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570；RadiForce GX570-AREizo Corporation K243221RadiForce RX570；RadiForce RX570-AREizo Corporation K243031LCD 螢幕 C310S、G310S、C316S、G316S、C616WShenzhen Beacon Display Technology Co., Ltd.

官方來源

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