FDA 510(k)

CONTOUR NEXT ONE 血糖监测系统

K号: K160682 · 2016-11-17

决定日期2016-11-17

产品代码NBW

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

CONTOUR NEXT ONE 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 2016-11-17 under 510(k) number K160682. 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 ONE Blood Glucose Monitoring System?

CONTOUR NEXT ONE Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Ascensia Diabetes Care. The 510(k) number is K160682.

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

CONTOUR NEXT ONE Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K160682.

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

The FDA product code for CONTOUR NEXT ONE 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 K193407Contour® next GEN 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

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。