FDA 510(k)

维纳斯 bliss

K号: K190743 · 2019-06-25

决定日期2019-06-25

产品代码PBX

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决定实质等同

器械摘要

Venus Bliss is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K190743. 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 Venus Bliss?

Venus Bliss is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K190743.

When did Venus Bliss receive FDA 510(k) clearance?

Venus Bliss received FDA 510(k) clearance on 2019-06-25, under 510(k) number K190743.

Who is the listed applicant for Venus Bliss?

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

What is the FDA product code for Venus Bliss?

The FDA product code for Venus Bliss is PBX.

列明Venus Concept USA, 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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官方来源

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