FDA 510(k)

古董藝術大眾

K 號：K191794 · 2019-10-03

決定日期2019-10-03

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Vintage Art Universal is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K191794. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vintage Art Universal?

Vintage Art Universal is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Shofu Dental Corporation. The 510(k) number is K191794.

When did Vintage Art Universal receive FDA 510(k) clearance?

Vintage Art Universal received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191794.

Who is the listed applicant for Vintage Art Universal?

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

What is the FDA product code for Vintage Art Universal?

The FDA product code for Vintage Art Universal is EIH.

其他以 Shofu Dental Corporation 為申請人之記錄

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相關器械（代碼：EIH）

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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