FDA 510(k)

TRUE METRIX GO Self Monitoring Blood Glucose System

K号: K143548 · 2016-04-01

决定日期2016-04-01

产品代码NBW

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决定实质等同

器械摘要

TRUE METRIX GO Self Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Trividia Health, Inc.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K143548. 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 TRUE METRIX GO Self Monitoring Blood Glucose System?

TRUE METRIX GO Self Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Trividia Health, Inc.. The 510(k) number is K143548.

When did TRUE METRIX GO Self Monitoring Blood Glucose System receive FDA 510(k) clearance?

TRUE METRIX GO Self Monitoring Blood Glucose System received FDA 510(k) clearance on 2016-04-01, under 510(k) number K143548.

Who is the listed applicant for TRUE METRIX GO Self Monitoring Blood Glucose System?

FDA 510(k)记录中列出Trividia Health, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for TRUE METRIX GO Self Monitoring Blood Glucose System?

The FDA product code for TRUE METRIX GO Self Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

列明Trividia Health, 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。

K262116TRUE METRIX 自监测血糖系统

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。

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