FDA 510(k)

智能无线健身设备（型号：AST-301，AST-302，AST-303）

K号: K182136 · 2019-10-10

决定日期2019-10-10

产品代码NUH

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

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K182136. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K182136.

When did Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) receive FDA 510(k) clearance?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) received FDA 510(k) clearance on 2019-10-10, under 510(k) number K182136.

Who is the listed applicant for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

The FDA product code for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is NUH.

列明Shenzhen Osto Technology Co., Ltd.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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相关器械（代码：NUH）

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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