FDA 510(k)

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K号: K201475 · 2020-10-28

决定日期2020-10-28

产品代码PBX

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决定实质等同

器械摘要

Ultimate Contour, Ultimate Contour Mini is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K201475. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultimate Contour, Ultimate Contour Mini?

Ultimate Contour, Ultimate Contour Mini is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is CAO Group, Inc.. The 510(k) number is K201475.

When did Ultimate Contour, Ultimate Contour Mini receive FDA 510(k) clearance?

Ultimate Contour, Ultimate Contour Mini received FDA 510(k) clearance on 2020-10-28, under 510(k) number K201475.

Who is the listed applicant for Ultimate Contour, Ultimate Contour Mini?

The FDA 510(k) record lists CAO Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultimate Contour, Ultimate Contour Mini?

The FDA product code for Ultimate Contour, Ultimate Contour Mini is PBX.

列明CAO Group, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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