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FDA 510(k)

12MP 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)

K 號：K231026 · 2023-08-18

申請人Shenzhen Beacon Display Technology Co., Ltd.
決定日期2023-08-18
產品代碼PGY
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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

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。

K252780LCD 螢幕（CL1902A，CL2103F）K253242LCD 螢幕（C1216W、C822W、C821W）K2331198MP 彩色 LCD 屏幕C811W, C811WT, PA27 和 PA27TK243031LCD 螢幕 C310S、G310S、C316S、G316S、C616WK240310LCD 螢幕 C310S、G310S、C316S、G316S、C616WK2338975MP 彩色 LCD 监视器/ 5MP 单色 LCD 监视器（C510S，G510S，CB5MP，MB5MP，C516S，G516S）

查看所有 14 項裝置 →

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 CorporationK261213醫療監視器（40HT513D）Lg Electronics.IncK252780LCD 螢幕（CL1902A，CL2103F）Shenzhen Beacon Display Technology Co., Ltd.K253242LCD 螢幕（C1216W、C822W、C821W）Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570；RadiForce GX570-AREizo CorporationK243221RadiForce RX570；RadiForce RX570-AREizo Corporation

官方來源

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