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FDA 510(k)

Confidence Blood Glucose Monitoring System

K-Number: K173658 · 2018-08-21

ApplicantApplied Biomedical, LLC
Decision Date2018-08-21
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Confidence Blood Glucose Monitoring System is a medical device manufactured by Applied Biomedical, LLC. It received FDA 510(k) clearance on 2018-08-21 under approval number K173658. 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 Confidence Blood Glucose Monitoring System?

Confidence Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Applied Biomedical, LLC. The 510(k) number is K173658.

When was Confidence Blood Glucose Monitoring System approved by the FDA?

Confidence Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-08-21, under approval number K173658.

What company makes Confidence Blood Glucose Monitoring System?

Confidence Blood Glucose Monitoring System is manufactured by Applied Biomedical, LLC.

What is the FDA product code for Confidence Blood Glucose Monitoring System?

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

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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)

Related Devices (Code: NBW)

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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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