FDA 510(k)

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

Número K: K152599 · 2016-07-20

Data da decisão2016-07-20

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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