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FDA 510(k)

Dario Blood Glucose Monitoring System

K-Number: K163159 · 2017-07-19

ApplicantLabstyle Innovations, Ltd.
Decision Date2017-07-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dario Blood Glucose Monitoring System is a medical device manufactured by Labstyle Innovations, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under approval number K163159. 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 Dario Blood Glucose Monitoring System?

Dario Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Labstyle Innovations, Ltd.. The 510(k) number is K163159.

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

Dario Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-07-19, under approval number K163159.

What company makes Dario Blood Glucose Monitoring System?

Dario Blood Glucose Monitoring System is manufactured by Labstyle Innovations, Ltd..

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

The FDA product code for Dario 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

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