Kudu
K号: K151492 · 2016-05-20
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申请人R82 A/S
决定日期2016-05-20
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：IOR）
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官方来源
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