FDA 510(k)

Llis, Vittra APS

K 號：K191306 · 2019-12-16

決定日期2019-12-16

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Llis, Vittra APS is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K191306. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Llis, Vittra APS?

Llis, Vittra APS is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Dentscare Ltda. The 510(k) number is K191306.

When did Llis, Vittra APS receive FDA 510(k) clearance?

Llis, Vittra APS received FDA 510(k) clearance on 2019-12-16, under 510(k) number K191306.

Who is the listed applicant for Llis, Vittra APS?

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

What is the FDA product code for Llis, Vittra APS?

The FDA product code for Llis, Vittra APS is EBF.

其他以 Dentscare Ltda 為申請人之記錄

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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相關器械（代碼：EBF）

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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