FDA 510(k)

FreeStyle Precision Neo血糖测试条

K号: K171941 · 2017-09-27

决定日期2017-09-27

产品代码NBW

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决定实质等同

器械摘要

FreeStyle Precision Neo Blood Glucose Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K171941. 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 FreeStyle Precision Neo Blood Glucose Test Strips?

FreeStyle Precision Neo Blood Glucose Test Strips is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K171941.

When did FreeStyle Precision Neo Blood Glucose Test Strips receive FDA 510(k) clearance?

FreeStyle Precision Neo Blood Glucose Test Strips received FDA 510(k) clearance on 2017-09-27, under 510(k) number K171941.

Who is the listed applicant for FreeStyle Precision Neo Blood Glucose Test Strips?

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

What is the FDA product code for FreeStyle Precision Neo Blood Glucose Test Strips?

The FDA product code for FreeStyle Precision Neo Blood Glucose Test Strips is NBW. This falls under the OB/GYN category.

列明Abbott Diabetes Care, Inc.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。

K233537FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统 K223435FreeStyle Libre 3连续血糖监测系统；FreeStyle Libre 2闪式血糖监测系统 K222447FreeStyle Libre 2闪式血糖监测系统；Freestyle Libre 3连续血糖监测系统 K223537FreeStyle Libre 2系统，FreeStyle Libre 3系统 K213996FreeStyle Libre 3连续血糖监测系统 K212132FreeStyle Libre 3连续血糖监测系统

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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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