FDA 510(k)

MultiSure GK Link 血糖和酮体监测系统

K号: K201880 · 2021-10-15

决定日期2021-10-15

产品代码NBW

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决定实质等同

器械摘要

MultiSure GK Link Blood Glucose and Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K201880. 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 MultiSure GK Link Blood Glucose and Ketone Monitoring System?

MultiSure GK Link Blood Glucose and Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K201880.

When did MultiSure GK Link Blood Glucose and Ketone Monitoring System receive FDA 510(k) clearance?

MultiSure GK Link Blood Glucose and Ketone Monitoring System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K201880.

Who is the listed applicant for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

The FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System is NBW. This falls under the OB/GYN category.

列明Apex BioTechnology Corp.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。

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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。

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官方来源

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