FDA 510(k)

颈部护理治疗仪，型号：SYK 509B

K号: K172897 · 2018-12-07

决定日期2018-12-07

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

Neck Care Therapy, Model: SYK 509B 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 2018-12-07 under 510(k) number K172897. 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 Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172897.

When did Neck Care Therapy, Model: SYK 509B receive FDA 510(k) clearance?

Neck Care Therapy, Model: SYK 509B received FDA 510(k) clearance on 2018-12-07, under 510(k) number K172897.

Who is the listed applicant for Neck Care Therapy, Model: SYK 509B?

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 Neck Care Therapy, Model: SYK 509B?

The FDA product code for Neck Care Therapy, Model: SYK 509B 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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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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