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FDA 510(k)

Smart Neck Stimulator

K号: K200558 · 2021-10-04

申请人Guandong Skg Intelligent Technology Co., Ltd.
决定日期2021-10-04
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

Smart Neck Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K200558. 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 Smart Neck Stimulator?

Smart Neck Stimulator is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. The 510(k) number is K200558.

When did Smart Neck Stimulator receive FDA 510(k) clearance?

Smart Neck Stimulator received FDA 510(k) clearance on 2021-10-04, under 510(k) number K200558.

Who is the listed applicant for Smart Neck Stimulator?

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

What is the FDA product code for Smart Neck Stimulator?

The FDA product code for Smart Neck Stimulator is NUH.

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