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FDA 510(k)

LED 面部護膚罩

K 號:K230351 · 2023-05-05

決定日期2023-05-05
產品代碼OHS
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

LED Facial Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K230351. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.. The 510(k) number is K230351.

When did LED Facial Mask receive FDA 510(k) clearance?

LED Facial Mask received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230351.

Who is the listed applicant for LED Facial Mask?

The FDA 510(k) record lists Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OHS.

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相關器械(代碼:OHS)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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