Kudu
K-Number: K151492 · 2016-05-20
ApplicantR82 A/S
Decision Date2016-05-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Kudu is the device name listed in this FDA 510(k) record. The listed applicant is R82 A/S. It received FDA 510(k) clearance on 2016-05-20 under 510(k) 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. The listed applicant is R82 A/S. The 510(k) number is K151492.
When did Kudu receive FDA 510(k) clearance?
Kudu received FDA 510(k) clearance on 2016-05-20, under 510(k) number K151492.
Who is the listed applicant for Kudu?
The FDA 510(k) record lists R82 A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kudu?
The FDA product code for Kudu is IOR.
Related Devices (Code: IOR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.