FDA 510(k)

Aimanfun Lumea Comfort

K 號：K190820 · 2019-10-02

決定日期2019-10-02

產品代碼OHT

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

Aimanfun Lumea Comfort is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K190820. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aimanfun Lumea Comfort?

Aimanfun Lumea Comfort is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K190820.

When did Aimanfun Lumea Comfort receive FDA 510(k) clearance?

Aimanfun Lumea Comfort received FDA 510(k) clearance on 2019-10-02, under 510(k) number K190820.

Who is the listed applicant for Aimanfun Lumea Comfort?

FDA 510(k) 記錄將高圓塑料產品有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aimanfun Lumea Comfort?

The FDA product code for Aimanfun Lumea Comfort is OHT.

其他以 Kam Yuen Plastic Products , 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。

K260767臉部美顏設備（臉部面膜LED美顏設備 A-901；臉部LED & EMS美顏設備 A-902；臉部面膜LED & EMS美顏設備 A-907）K230107Aimanfun Lumea Comfort, 型號：A-2788, A-2789和A-3588 K213027雷射生髮梳 K213025雷射生髮頭盔 K212907Aimanfun Lumea Comfort, A-2789/A-3588

相關器械（代碼：OHT）

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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