FDA 510(k)

UbiqVue™ 2A 多參數系統 (UX2550)

K 號：K242018 · 2024-11-12

決定日期2024-11-12

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

UbiqVue™ 2A Multi-parameter System (UX2550) is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242018. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UbiqVue™ 2A Multi-parameter System (UX2550)?

UbiqVue™ 2A Multi-parameter System (UX2550) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Lifesignals, Inc.. The 510(k) number is K242018.

When did UbiqVue™ 2A Multi-parameter System (UX2550) receive FDA 510(k) clearance?

UbiqVue™ 2A Multi-parameter System (UX2550) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242018.

Who is the listed applicant for UbiqVue™ 2A Multi-parameter System (UX2550)?

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

What is the FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550)?

The FDA product code for UbiqVue™ 2A Multi-parameter System (UX2550) is DRG.

其他以 Lifesignals, Inc. 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。

K261569UbiqVue™ 2AYe 心臟系統 (UX2253)K202868LifeSignals 多參數遠端監測平台 K200690LifeSignals 心電圖遠端監測貼片平台

相關器械（代碼：DRG）

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。

K261569UbiqVue™ 2AYe 心臟系統 (UX2253)Lifesignals, Inc.K252984Perin醫療系統（PHD80060-2）Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259遠端復健 Aermos 心肺復健設備The ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K241101生物按鈕系統Biointellisense, Inc.

官方來源

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