FDA 510(k)

Exiciple

K 號：K191086 · 2019-12-11

決定日期2019-12-11

產品代碼FTC

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

Exciplex is the device name listed in this FDA 510(k) record. The listed applicant is Clarteis. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K191086. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Exciplex?

Exciplex is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Clarteis. The 510(k) number is K191086.

When did Exciplex receive FDA 510(k) clearance?

Exciplex received FDA 510(k) clearance on 2019-12-11, under 510(k) number K191086.

Who is the listed applicant for Exciplex?

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

What is the FDA product code for Exciplex?

The FDA product code for Exciplex is FTC.

其他以 Clarteis 為申請人之記錄

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K171702Exciplеx308nm

相關器械（代碼：FTC）

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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官方來源

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