FDA 510(k)

LEDEX WL070+

K 號：K163605 · 2017-01-19

決定日期2017-01-19

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

LEDEX WL070+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K163605. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LEDEX WL070+?

LEDEX WL070+ is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Dentmate Technology Co. , Ltd.. The 510(k) number is K163605.

When did LEDEX WL070+ receive FDA 510(k) clearance?

LEDEX WL070+ received FDA 510(k) clearance on 2017-01-19, under 510(k) number K163605.

Who is the listed applicant for LEDEX WL070+?

The FDA 510(k) record lists Dentmate Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEDEX WL070+?

The FDA product code for LEDEX WL070+ is EBZ.

其他以 Dentmate Technology Co. , Ltd. 為申請人之記錄

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K221194LEDEX

相關器械（代碼：EBZ）

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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