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FDA 510(k)

Tua Face Fitness / Tua Trend Face 产品名称:Tua Face Fitness / Tua Trend Face 医疗设备监管文本: 根据《医疗器械监督管理条例》,本产品已通过FDA(美国食品药品监督管理局)510(k)预市场批准,PMA(上市前批准)或NCT(临床试验注册号)为______,PMID(PubMed ID)为______。 产品标识符:______ 产品网址:______

K号: K192077 · 2020-09-30

决定日期2020-09-30
产品代码NFO
咨询委员会NE 请注意,您提供的文本“NE”不足以进行翻译,因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本,以便我能够进行准确的翻译。
决定实质等同

器械摘要

Tua Face Fitness / Tua Trend Face is the device name listed in this FDA 510(k) record. The listed applicant is Vupiesse S.R.L. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K192077. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tua Face Fitness / Tua Trend Face?

Tua Face Fitness / Tua Trend Face is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Vupiesse S.R.L. The 510(k) number is K192077.

When did Tua Face Fitness / Tua Trend Face receive FDA 510(k) clearance?

Tua Face Fitness / Tua Trend Face received FDA 510(k) clearance on 2020-09-30, under 510(k) number K192077.

Who is the listed applicant for Tua Face Fitness / Tua Trend Face?

The FDA 510(k) record lists Vupiesse S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tua Face Fitness / Tua Trend Face?

The FDA product code for Tua Face Fitness / Tua Trend Face is NFO.

相关临床试验

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。

相关器械(代码:NFO)

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。

官方来源

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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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