FDA 510(k)

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR

K-Number: K122370 · 2013-09-26

Decision Date2013-09-26

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K122370. 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 MONITOR?

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Bayer Healthcare. The 510(k) number is K122370.

When did CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR receive FDA 510(k) clearance?

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR received FDA 510(k) clearance on 2013-09-26, under 510(k) number K122370.

Who is the listed applicant for CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR?

The FDA 510(k) record lists Bayer Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR?

The FDA product code for CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR is NBW. This falls under the OB/GYN category.

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Other records listing Bayer Healthcare as applicant

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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.