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FDA 510(k)

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K 號：K242750 · 2025-06-05

申請人Nihon Kohden Digital Health Solutions, LLC
決定日期2025-06-05
產品代碼MSX
諮詢委員會履歷
決定相當於

器材摘要

Central Station is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Digital Health Solutions, LLC. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K242750. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Central Station?

Central Station is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Nihon Kohden Digital Health Solutions, LLC. The 510(k) number is K242750.

When did Central Station receive FDA 510(k) clearance?

Central Station received FDA 510(k) clearance on 2025-06-05, under 510(k) number K242750.

Who is the listed applicant for Central Station?

The FDA 510(k) record lists Nihon Kohden Digital Health Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Central Station?

The FDA product code for Central Station is MSX.

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

相關器械（代碼：MSX）

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。

K261287數位統計護理Ascom Ums Srl UnipersonaleK260211儀表板（P007000）Hill-Rom, Inc.K261367柯薩諾 CardioWatch 287-2 系統Corsano Health B.V.K253654IntelliVue測量架6000（867317）Philips Medizin Systeme Böblingen GmbHK243270虎連接警報管理TigerconnectK242728BeneVision 中央監控系統Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

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