FDA 510(k)

HIGHERDOSE 紅外線及紅光面膜 (MK66-L)

K 號：K241933 · 2024-09-27

申請人Shenzhen Kaiyan Medical Equipment Co., Ltd.

決定日期2024-09-27

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

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241933. 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 HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K241933.

When did HIGHERDOSE Red and Infrared Light Mask (MK66-L) receive FDA 510(k) clearance?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241933.

Who is the listed applicant for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

FDA 510(k) 記錄將深圳凱亞醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

The FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L) is OHS.

其他以 Shenzhen Kaiyan Medical Equipment Co., Ltd. 為申請人之記錄

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。

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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。

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官方來源

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