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FDA 510(k)

LifeSignals WiPoint 生醫感測器_iOS 接收器_應用系統 (LifeSignals WiPatch & WiApp 系統)

K 號：K172011 · 2018-06-14

申請人Hmicro, Inc.
決定日期2018-06-14
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is the device name listed in this FDA 510(k) record. The listed applicant is Hmicro, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172011. 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 LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Hmicro, Inc.. The 510(k) number is K172011.

When did LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) receive FDA 510(k) clearance?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172011.

Who is the listed applicant for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

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

What is the FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

The FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) 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。

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