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FDA 510(k)

BC-001+ 痤瘡淨化器

K 號:K170260 · 2017-04-25

決定日期2017-04-25
產品代碼OLP
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

BC-001+ Acne Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K170260. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BC-001+ Acne Purifier?

BC-001+ Acne Purifier is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K170260.

When did BC-001+ Acne Purifier receive FDA 510(k) clearance?

BC-001+ Acne Purifier received FDA 510(k) clearance on 2017-04-25, under 510(k) number K170260.

Who is the listed applicant for BC-001+ Acne Purifier?

The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-001+ Acne Purifier?

The FDA product code for BC-001+ Acne Purifier is OLP.

相關臨床試驗

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其他以 Oriental Inspiration Limited 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。

相關器械(代碼:OLP)

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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