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FDA 510(k)

higi Station（含體成分和攤移式袖帶外殼），higi Station（含體成分和固定式袖帶外殼）

K 號：K172739 · 2017-10-10

申請人Higi Sh, LLC
決定日期2017-10-10
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is the device name listed in this FDA 510(k) record. The listed applicant is Higi Sh, LLC. It received FDA 510(k) clearance on 2017-10-10 under 510(k) number K172739. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is a medical device that received FDA 510(k) clearance on 2017-10-10. The listed applicant is Higi Sh, LLC. The 510(k) number is K172739.

When did higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) receive FDA 510(k) clearance?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) received FDA 510(k) clearance on 2017-10-10, under 510(k) number K172739.

Who is the listed applicant for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

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

What is the FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

The FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is DXN.

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：DXN）

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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官方來源

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