FDA 510(k)

Contour® next GEN 血糖监测系统

K号: K193407 · 2021-12-23

决定日期2021-12-23

产品代码NBW

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决定实质等同

器械摘要

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. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K193407. 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.

常见问题

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 2021-12-23. The listed applicant is Ascensia Diabetes Care. The 510(k) number is K193407.

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 2021-12-23, under 510(k) number K193407.

Who is the listed applicant for Contour® next GEN Blood Glucose Monitoring System?

FDA 510(k)记录显示Ascensia Diabetes Care为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Ascensia Diabetes Care为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260545CONTOUR® PLUS BLUE 血糖监测系统；CONTOUR® NEXT GEN 血糖监测系统；CONTOUR® NEXT ONE 血糖监测系统 K231679CONTOUR® PLUS BLUE 血糖监测系统 K210687CONTOUR® NEXT ONE 血糖监测系统 K191286CONTOUR® NEXT 血糖监测系统，CONTOUR® NEXT USB 血糖监测系统，CONTOUR® NEXT ONE 血糖监测系统，CONTOUR® NEXT EZ 血糖监测系统，CONTOUR® NEXT LINK 无线血糖监测系统 K160682CONTOUR NEXT ONE 血糖监测系统

相关器械（代码：NBW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260545CONTOUR® PLUS BLUE 血糖监测系统；CONTOUR® NEXT GEN 血糖监测系统；CONTOUR® NEXT ONE 血糖监测系统Ascensia Diabetes Care K262116TRUE METRIX 自监测血糖系统Trividia Health, Inc.K250085On Call® Sure GK 血糖 & 酮体监测系统；On Call® Sure Sync GK 血糖 & 酮体监测系统ACON Laboratories, Inc.K243060TeleRPM Gen2 血糖监测系统Guangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST 血糖监测系统 Max TelBionime Corporation K240640Sejoy 血糖监测系统；Sejoy 先进链接血糖监测系统Sejoy Biomedical Co., Ltd.

官方来源

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