FDA 510(k)

Venus RF 系统 - Heal 系列系列

K号: K182094 · 2019-02-01

决定日期2019-02-01

产品代码PBX

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决定实质等同

器械摘要

Family of Venus RF Systems - Heal 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 2019-02-01 under 510(k) number K182094. 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 Family of Venus RF Systems - Heal?

Family of Venus RF Systems - Heal is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K182094.

When did Family of Venus RF Systems - Heal receive FDA 510(k) clearance?

Family of Venus RF Systems - Heal received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182094.

Who is the listed applicant for Family of Venus RF Systems - Heal?

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 Family of Venus RF Systems - Heal?

The FDA product code for Family of Venus RF Systems - Heal 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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