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FDA 510(k)

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

K-Number: K160430 · 2016-06-24

ApplicantAscensia Diabetes Care U.S., Inc.
Decision Date2016-06-24
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is a medical device manufactured by Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2016-06-24 under approval number K160430. 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 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System?

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K160430.

When was Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System approved by the FDA?

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-06-24, under approval number K160430.

What company makes Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System?

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is manufactured by Ascensia Diabetes Care U.S., Inc..

What is the FDA product code for Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System?

The FDA product code for Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

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Other Devices by Ascensia Diabetes Care U.S., Inc.

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

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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