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FDA 510(k)

NuStat

K-Number: K183190 · 2019-09-25

Decision Date2019-09-25
Product CodePOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NuStat is a medical device manufactured by Beeken Biomedical, LLC. It received FDA 510(k) clearance on 2019-09-25 under approval number K183190. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuStat?

NuStat is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Beeken Biomedical, LLC. The 510(k) number is K183190.

When was NuStat approved by the FDA?

NuStat received FDA 510(k) clearance on 2019-09-25, under approval number K183190.

What company makes NuStat?

NuStat is manufactured by Beeken Biomedical, LLC.

What is the FDA product code for NuStat?

The FDA product code for NuStat is POD.

Other Devices by Beeken Biomedical, LLC

Related Devices (Code: POD)

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.