FDA 510(k)

VivaChek Link Plus Blood Glucose Monitoring System

Número K: K233058 · 2023-12-22

RequerenteVivachek Biotech (Hangzhou) Co., Ltd.

Data da decisão2023-12-22

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

VivaChek Link Plus Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233058. 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 VivaChek Link Plus Blood Glucose Monitoring System?

VivaChek Link Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K233058.

When did VivaChek Link Plus Blood Glucose Monitoring System receive FDA 510(k) clearance?

VivaChek Link Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233058.

Who is the listed applicant for VivaChek Link Plus Blood Glucose Monitoring System?

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

What is the FDA product code for VivaChek Link Plus Blood Glucose Monitoring System?

The FDA product code for VivaChek Link Plus Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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