FDA 510(k)

CUBE 空气净化器

K号: K211139 · 2021-11-26

决定日期2021-11-26

产品代码FRA

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

CUBE Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K211139. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CUBE Air Purifier?

CUBE Air Purifier is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K211139.

When did CUBE Air Purifier receive FDA 510(k) clearance?

CUBE Air Purifier received FDA 510(k) clearance on 2021-11-26, under 510(k) number K211139.

Who is the listed applicant for CUBE Air Purifier?

FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for CUBE Air Purifier?

The FDA product code for CUBE Air Purifier is FRA.

列明Samsung Electronics Co., Ltd.为申报人的其他记录

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