FDA 510(k)

CX50N, CX50YQS

K 號：K160351 · 2016-04-07

決定日期2016-04-07

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

CX50N, CX50YQS is the device name listed in this FDA 510(k) record. The listed applicant is Wide Corporation. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K160351. 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 CX50N, CX50YQS?

CX50N, CX50YQS is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Wide Corporation. The 510(k) number is K160351.

When did CX50N, CX50YQS receive FDA 510(k) clearance?

CX50N, CX50YQS received FDA 510(k) clearance on 2016-04-07, under 510(k) number K160351.

Who is the listed applicant for CX50N, CX50YQS?

The FDA 510(k) record lists Wide Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CX50N, CX50YQS?

The FDA product code for CX50N, CX50YQS is PGY.

其他以 Wide Corporation 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。

K222719CX50N K222716MX50N K222722CW60N K222717CL24N K210493CX30N (CX30PQX)K210491CW120N

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 Corporation K261213醫療監視器（40HT513D）Lg Electronics.Inc K252780LCD 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 Corporation K243221RadiForce RX570；RadiForce RX570-AREizo Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。