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FDA 510(k)

HEX 紫外線燙膚機

K 號:K152336 · 2016-05-02

決定日期2016-05-02
產品代碼LEJ
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

HEX tanning booth is the device name listed in this FDA 510(k) record. The listed applicant is J & B Products Ltd Dba Hex Tanning. It received FDA 510(k) clearance on 2016-05-02 under 510(k) number K152336. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HEX tanning booth?

HEX tanning booth is a medical device that received FDA 510(k) clearance on 2016-05-02. The listed applicant is J & B Products Ltd Dba Hex Tanning. The 510(k) number is K152336.

When did HEX tanning booth receive FDA 510(k) clearance?

HEX tanning booth received FDA 510(k) clearance on 2016-05-02, under 510(k) number K152336.

Who is the listed applicant for HEX tanning booth?

The FDA 510(k) record lists J & B Products Ltd Dba Hex Tanning as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEX tanning booth?

The FDA product code for HEX tanning booth is LEJ.

相關臨床試驗

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相關器械(代碼:LEJ)

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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