FDA 510(k)

VivaChek Link Plus Blood Glucose Monitoring System

K-Number: K233058 · 2023-12-22

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.

Decision Date2023-12-22

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VivaChek Link Plus Blood Glucose Monitoring System is a medical device manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval 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.

Frequently Asked Questions

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. It is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K233058.

When was VivaChek Link Plus Blood Glucose Monitoring System approved by the FDA?

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

What company makes VivaChek Link Plus Blood Glucose Monitoring System?

VivaChek Link Plus Blood Glucose Monitoring System is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd..

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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Other Devices by Vivachek Biotech (Hangzhou) Co., Ltd.

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Related Devices (Code: NBW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.