FDA 510(k)

PRODIGY ASTRO 血糖监测系统，PRODIGY ASTRO PRO 血糖监测系统

K号: K152599 · 2016-07-20

决定日期2016-07-20

产品代码NBW

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决定实质等同

器械摘要

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ok Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152599. 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 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System?

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Ok Biotech Co., Ltd.. The 510(k) number is K152599.

When did PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System receive FDA 510(k) clearance?

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152599.

Who is the listed applicant for PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System?

The FDA 510(k) record lists Ok Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System?

The FDA product code for PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

列明Ok Biotech Co., Ltd.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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