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FDA 510(k)

PixoTest 血糖監測系統

K 號：K163087 · 2017-11-02

申請人Ixensor Company , Ltd.
決定日期2017-11-02
產品代碼NBW
諮詢委員會CH
決定相當於

器材摘要

PixoTest Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ixensor Company , Ltd.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K163087. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the PixoTest Blood Glucose Monitoring System?

PixoTest Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Ixensor Company , Ltd.. The 510(k) number is K163087.

When did PixoTest Blood Glucose Monitoring System receive FDA 510(k) clearance?

PixoTest Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-11-02, under 510(k) number K163087.

Who is the listed applicant for PixoTest Blood Glucose Monitoring System?

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

What is the FDA product code for PixoTest Blood Glucose Monitoring System?

The FDA product code for PixoTest Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

相關臨床試驗

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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：NBW）

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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