免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Unite Connect 醫療系統用連接器

K 號：K180566 · 2018-04-03

申請人Ascom Sweden AB
決定日期2018-04-03
產品代碼MSX
諮詢委員會履歷
決定相當於

器材摘要

Unite Connect for Clinical Systems is the device name listed in this FDA 510(k) record. The listed applicant is Ascom Sweden AB. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180566. 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 Unite Connect for Clinical Systems?

Unite Connect for Clinical Systems is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Ascom Sweden AB. The 510(k) number is K180566.

When did Unite Connect for Clinical Systems receive FDA 510(k) clearance?

Unite Connect for Clinical Systems received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180566.

Who is the listed applicant for Unite Connect for Clinical Systems?

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

What is the FDA product code for Unite Connect for Clinical Systems?

The FDA product code for Unite Connect for Clinical Systems 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

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。

↑