FDA 510(k)

Evogue牙科單位

K 號：K152100 · 2016-01-22

決定日期2016-01-22

產品代碼EIA

諮詢委員會DE

決定相當於

器材摘要

Evogue Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont Corporation. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152100. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Evogue Dental Unit?

Evogue Dental Unit is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Takara Belmont Corporation. The 510(k) number is K152100.

When did Evogue Dental Unit receive FDA 510(k) clearance?

Evogue Dental Unit received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152100.

Who is the listed applicant for Evogue Dental Unit?

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

What is the FDA product code for Evogue Dental Unit?

The FDA product code for Evogue Dental Unit is EIA.

其他以 Takara Belmont Corporation 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：EIA）

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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