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FDA 510(k)

亮

K 號:K161849 · 2016-07-29

決定日期2016-07-29
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

Bright is the device name listed in this FDA 510(k) record. The listed applicant is Tanda Beauty Canada, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161849. 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 Bright?

Bright is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Tanda Beauty Canada, Inc.. The 510(k) number is K161849.

When did Bright receive FDA 510(k) clearance?

Bright received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161849.

Who is the listed applicant for Bright?

The FDA 510(k) record lists Tanda Beauty Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bright?

The FDA product code for Bright 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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