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FDA 510(k)

AuraGen 123 吸脂系统(A123)

K号: K190278 · 2019-05-03

决定日期2019-05-03
产品代码MUU
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

AuraGen 123 Suction Lipoplasty System (A123) is the device name listed in this FDA 510(k) record. The listed applicant is Auragen Aesthetics, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190278. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AuraGen 123 Suction Lipoplasty System (A123)?

AuraGen 123 Suction Lipoplasty System (A123) is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Auragen Aesthetics, LLC. The 510(k) number is K190278.

When did AuraGen 123 Suction Lipoplasty System (A123) receive FDA 510(k) clearance?

AuraGen 123 Suction Lipoplasty System (A123) received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190278.

Who is the listed applicant for AuraGen 123 Suction Lipoplasty System (A123)?

The FDA 510(k) record lists Auragen Aesthetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AuraGen 123 Suction Lipoplasty System (A123)?

The FDA product code for AuraGen 123 Suction Lipoplasty System (A123) is MUU.

相关临床试验

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相关器械(代码:MUU)

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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