FDA 510(k)

维纳斯 BlissMAX

K号: K213308 · 2022-01-12

决定日期2022-01-12

产品代码PBX

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决定实质等同

器械摘要

Venus BlissMAX 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 2022-01-12 under 510(k) number K213308. 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 BlissMAX?

Venus BlissMAX is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K213308.

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

Venus BlissMAX received FDA 510(k) clearance on 2022-01-12, under 510(k) number K213308.

Who is the listed applicant for Venus BlissMAX?

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 BlissMAX?

The FDA product code for Venus BlissMAX 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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