FDA 510(k)

泰森生物HT100-A血糖监测系统；泰森生物HT100-C血糖监测系统

K号: K182047 · 2018-11-29

决定日期2018-11-29

产品代码NBW

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决定实质等同

器械摘要

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Tyson Bioresearch, Inc.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K182047. 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 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System?

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Tyson Bioresearch, Inc.. The 510(k) number is K182047.

When did Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System receive FDA 510(k) clearance?

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-29, under 510(k) number K182047.

Who is the listed applicant for Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System?

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

What is the FDA product code for Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System?

The FDA product code for Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

列明Tyson Bioresearch, 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。

K182046泰森生物HS100血糖监测系统，泰森生物HS100-B血糖监测系统 K170079泰森生物HT100血糖监测系统，泰森生物HT100-B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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