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FDA 510(k)

Sejoy 血糖監測系統；Sejoy 先進連接血糖監測系統

K 號：K240640 · 2024-10-08

申請人Sejoy Biomedical Co., Ltd.
決定日期2024-10-08
產品代碼NBW
諮詢委員會CH
決定相當於

器材摘要

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sejoy Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-08 under 510(k) number K240640. 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 Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-10-08. The listed applicant is Sejoy Biomedical Co., Ltd.. The 510(k) number is K240640.

When did Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System receive FDA 510(k) clearance?

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-10-08, under 510(k) number K240640.

Who is the listed applicant for Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

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

What is the FDA product code for Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

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

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：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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官方來源

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