FDA 510(k)

Dario LC Blood Glucose Monitoring System

K-Number: K172723 · 2018-03-23

Decision Date2018-03-23

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Dario LC Blood Glucose Monitoring System is a medical device manufactured by Labstyle Innovation, Ltd.. It received FDA 510(k) clearance on 2018-03-23 under approval number K172723. 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 LC Blood Glucose Monitoring System?

Dario LC Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-03-23. It is manufactured by Labstyle Innovation, Ltd.. The 510(k) number is K172723.

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

Dario LC Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-03-23, under approval number K172723.

What company makes Dario LC Blood Glucose Monitoring System?

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

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

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

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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.