FDA 510(k)

NoCoding1 Plus Blood Glucose Monitoring System

K-Number: K160742 · 2016-12-16

Decision Date2016-12-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NoCoding1 Plus Blood Glucose Monitoring System is a medical device manufactured by I-Sens, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K160742. 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 NoCoding1 Plus Blood Glucose Monitoring System?

NoCoding1 Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by I-Sens, Inc.. The 510(k) number is K160742.

When was NoCoding1 Plus Blood Glucose Monitoring System approved by the FDA?

NoCoding1 Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-12-16, under approval number K160742.

What company makes NoCoding1 Plus Blood Glucose Monitoring System?

NoCoding1 Plus Blood Glucose Monitoring System is manufactured by I-Sens, Inc..

What is the FDA product code for NoCoding1 Plus Blood Glucose Monitoring System?

The FDA product code for NoCoding1 Plus Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Other Devices by I-Sens, Inc.

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Related Devices (Code: NBW)

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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.