FDA 510(k)

CONTOUR® PLUS BLUE 血糖監測系統

K 號：K231679 · 2024-02-23

決定日期2024-02-23

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

CONTOUR® PLUS BLUE Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K231679. 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 CONTOUR® PLUS BLUE Blood Glucose Monitoring System?

CONTOUR® PLUS BLUE Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Ascensia Diabetes Care. The 510(k) number is K231679.

When did CONTOUR® PLUS BLUE Blood Glucose Monitoring System receive FDA 510(k) clearance?

CONTOUR® PLUS BLUE Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-02-23, under 510(k) number K231679.

Who is the listed applicant for CONTOUR® PLUS BLUE Blood Glucose Monitoring System?

FDA 510(k) 記錄將 Ascensia Diabetes Care 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CONTOUR® PLUS BLUE Blood Glucose Monitoring System?

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

其他以 Ascensia Diabetes Care 為申請人之記錄

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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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。

K260545CONTOUR® PLUS BLUE 血糖監測系統；CONTOUR® NEXT GEN 血糖監測系統；CONTOUR® NEXT ONE 血糖監測系統Ascensia Diabetes Care K262116TRUE METRIX 自我監測血糖系統Trividia Health, Inc.K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統ACON Laboratories, Inc.K243060TeleRPM Gen2 血糖監測系統Guangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST 血糖監測系統 Max TelBionime Corporation K240640Sejoy 血糖監測系統；Sejoy 先進連接血糖監測系統Sejoy Biomedical Co., Ltd.

官方來源

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