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FDA 510(k)

IBL 5000 體驗室

K 號:K152405 · 2016-09-01

決定日期2016-09-01
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

IBL 5000 Tanning Booth is the device name listed in this FDA 510(k) record. The listed applicant is Ibl Acquisitions, LLC. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K152405. 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 IBL 5000 Tanning Booth?

IBL 5000 Tanning Booth is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Ibl Acquisitions, LLC. The 510(k) number is K152405.

When did IBL 5000 Tanning Booth receive FDA 510(k) clearance?

IBL 5000 Tanning Booth received FDA 510(k) clearance on 2016-09-01, under 510(k) number K152405.

Who is the listed applicant for IBL 5000 Tanning Booth?

The FDA 510(k) record lists Ibl Acquisitions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBL 5000 Tanning Booth?

The FDA product code for IBL 5000 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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