FDA 510(k)

Exciplеx308nm

K 號：K171702 · 2017-10-13

決定日期2017-10-13

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

Exciplex308nm is the device name listed in this FDA 510(k) record. The listed applicant is Clarteis. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K171702. 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 Exciplex308nm?

Exciplex308nm is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Clarteis. The 510(k) number is K171702.

When did Exciplex308nm receive FDA 510(k) clearance?

Exciplex308nm received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171702.

Who is the listed applicant for Exciplex308nm?

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 Exciplex308nm?

The FDA product code for Exciplex308nm is FTC.

其他以 Clarteis 為申請人之記錄

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K191086Exiciple

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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