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FDA 510(k)

UINCARE 家用

K 號：K172882 · 2018-05-10

申請人Uincare Corp.
決定日期2018-05-10
產品代碼LXJ
諮詢委員會PM
決定相當於

器材摘要

UINCARE HOME is the device name listed in this FDA 510(k) record. The listed applicant is Uincare Corp.. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K172882. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UINCARE HOME?

UINCARE HOME is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Uincare Corp.. The 510(k) number is K172882.

When did UINCARE HOME receive FDA 510(k) clearance?

UINCARE HOME received FDA 510(k) clearance on 2018-05-10, under 510(k) number K172882.

Who is the listed applicant for UINCARE HOME?

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

What is the FDA product code for UINCARE HOME?

The FDA product code for UINCARE HOME is LXJ.

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：LXJ）

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。

K192474VERAReflexion Health, Inc.K182333VeraReflexion Health, Inc.K180880DARI醫療設備規範文本翻譯： DARI HealthScientific Analytics, Inc.K171547Qualisys醫學設備規範文本 Qualisys臨床系統Qualisys ABK173931MindMotion™ GOMindmaze SAK162748MindMotionPROMindmaze SA

官方來源

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