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FDA 510(k)

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

K-Number: K160365 · 2016-09-28

ApplicantInfopia Co, Ltd.
Decision Date2016-09-28
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is a medical device manufactured by Infopia Co, Ltd.. It received FDA 510(k) clearance on 2016-09-28 under approval number K160365. 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 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Infopia Co, Ltd.. The 510(k) number is K160365.

When was BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System approved by the FDA?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-09-28, under approval number K160365.

What company makes BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is manufactured by Infopia Co, Ltd..

What is the FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

The FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional 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)

Related Devices (Code: NBW)

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Official Source

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