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FDA 510(k)

優健遠距醫療應用程序

K 號：K171406 · 2017-08-18

申請人United Health Group, Inc.
決定日期2017-08-18
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

Optum TeleHealth Application is the device name listed in this FDA 510(k) record. The listed applicant is United Health Group, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171406. 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 Optum TeleHealth Application?

Optum TeleHealth Application is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is United Health Group, Inc.. The 510(k) number is K171406.

When did Optum TeleHealth Application receive FDA 510(k) clearance?

Optum TeleHealth Application received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171406.

Who is the listed applicant for Optum TeleHealth Application?

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

What is the FDA product code for Optum TeleHealth Application?

The FDA product code for Optum TeleHealth Application is DRG.

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：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, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259遠端復健 Aermos 心肺復健設備The ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A 多參數系統 (UX2550)Lifesignals, Inc.

官方來源

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