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FDA 510(k)

Nustat XR

K-Number: K160578 · 2016-06-29

ApplicantBeeken Biomedical, LLC
Decision Date2016-06-29
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Nustat XR is a medical device manufactured by Beeken Biomedical, LLC. It received FDA 510(k) clearance on 2016-06-29 under approval number K160578. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nustat XR?

Nustat XR is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Beeken Biomedical, LLC. The 510(k) number is K160578.

When was Nustat XR approved by the FDA?

Nustat XR received FDA 510(k) clearance on 2016-06-29, under approval number K160578.

What company makes Nustat XR?

Nustat XR is manufactured by Beeken Biomedical, LLC.

What is the FDA product code for Nustat XR?

The FDA product code for Nustat XR is QSY.

Other Devices by Beeken Biomedical, LLC

K183190NuStat

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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.

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