FDA 510(k)

連接設備與語音控制的OR Hub，配備設備與語音控制的SDC4K資訊管理系統

K 號：K232157 · 2023-08-18

決定日期2023-08-18

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K232157. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Stryker Corporation. The 510(k) number is K232157.

When did Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control receive FDA 510(k) clearance?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232157.

Who is the listed applicant for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

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

What is the FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is GCJ.

其他以 Stryker 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。

K212194Stryker Q導航系統搭配頭顱導航軟體、CranialMask Tracker和顯微鏡Tracker、被動光學導航儀器、Mayfield基座搭配可屈節臂，以及導航針吸針，電磁導航儀器、精準定位系統 K223770Sonopet 1Q 3 7cm 1Q 大尺寸 K221728Aviator® 頸椎前方板 (ACP) 系統，LITe® 板系統，DynaTran™ 頸椎前方板 (ACP) 系統，Reflex™ 混合 ACP 系統，UniVise™ 棘突固定板 K221074OptaBlate 電波發生器，OptaBlate 探針，OptaBlate 微針注射器注射設備 K221098Scopis 耳鼻喉軟體，Scopis 耳鼻喉軟體搭配 TGS，Scopis 計劃軟體，電磁導航單元 K213824Sonopet iQ 超聲吸引器系統

查看所有 42 項裝置 →

相關器械（代碼：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE選擇系統Karl Storz SE & CO. KG K260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony Corporation K261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical Impact K261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

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。