FDA 510(k)

Demi Ultra

K号: K163064 · 2017-07-18

决定日期2017-07-18

产品代码EBZ

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决定实质等同

器械摘要

Demi Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K163064. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Demi Ultra?

Demi Ultra is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Kerr Corporation. The 510(k) number is K163064.

When did Demi Ultra receive FDA 510(k) clearance?

Demi Ultra received FDA 510(k) clearance on 2017-07-18, under 510(k) number K163064.

Who is the listed applicant for Demi Ultra?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Demi Ultra?

The FDA product code for Demi Ultra is EBZ.

列明Kerr Corporation为申报人的其他记录

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