FDA 510(k)

CONTOUR® NEXT GEN 血糖監測系統

K 號：K223293 · 2022-11-18

決定日期2022-11-18

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

CONTOUR® NEXT GEN Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K223293. 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® NEXT GEN Blood Glucose Monitoring System?

CONTOUR® NEXT GEN Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K223293.

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

CONTOUR® NEXT GEN Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K223293.

Who is the listed applicant for CONTOUR® NEXT GEN Blood Glucose Monitoring System?

The FDA 510(k) record lists Ascensia Diabetes Care U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR® NEXT GEN Blood Glucose Monitoring System?

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

其他以 Ascensia Diabetes Care U.S., Inc. 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。

K250813MICROLET®NEXT 2 鋸刺器 K241787CONTOUR® PLUS BLUE 血糖監測系統；CONTOUR® NEXT GEN 血糖監測系統 K241810MICROLET®NEXT 刺針 K220633MICROLET NEXT 穿刺器，MICROLET 刺針 K162336Contour Next EZ 血糖監測系統 K160430Contour Next Link 遥感式血糖監測系統，Contour Next 血糖監測系統

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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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