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FDA 510(k)

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

K-Number: K202739 · 2022-08-12

ApplicantBioland Technology, Ltd.
Decision Date2022-08-12
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is a medical device manufactured by Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2022-08-12 under approval number K202739. 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 Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Bioland Technology, Ltd.. The 510(k) number is K202739.

When was Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System approved by the FDA?

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-12, under approval number K202739.

What company makes Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is manufactured by Bioland Technology, Ltd..

What is the FDA product code for Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

The FDA product code for Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Bioland Technology, Ltd.

K201161Infrared Thermometer Model E127 K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B K191657Bioland Blood Glucose Monitoring System K201879Digital Thermometer Model T103, T104 K202934Blood Pressure Monitor K213011Infrared Thermometer (model: E201)

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Official Source

View on FDA Database →

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

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