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FDA 510(k)

Kudu

K-Number: K151492 · 2016-05-20

ApplicantR82 A/S
Decision Date2016-05-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Kudu is a medical device manufactured by R82 A/S. It received FDA 510(k) clearance on 2016-05-20 under approval number K151492. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kudu?

Kudu is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by R82 A/S. The 510(k) number is K151492.

When was Kudu approved by the FDA?

Kudu received FDA 510(k) clearance on 2016-05-20, under approval number K151492.

What company makes Kudu?

Kudu is manufactured by R82 A/S.

What is the FDA product code for Kudu?

The FDA product code for Kudu is IOR.

Related Devices (Code: IOR)

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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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