FDA 510(k)

G7，牙科手術單位及附件

K 號：K213749 · 2023-04-03

決定日期2023-04-03

產品代碼EIA

諮詢委員會DE

決定相當於

器材摘要

G7, Dental Operative Unit and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Company, Ltd.. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K213749. 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 G7, Dental Operative Unit and Accessories?

G7, Dental Operative Unit and Accessories is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Shinhung Company, Ltd.. The 510(k) number is K213749.

When did G7, Dental Operative Unit and Accessories receive FDA 510(k) clearance?

G7, Dental Operative Unit and Accessories received FDA 510(k) clearance on 2023-04-03, under 510(k) number K213749.

Who is the listed applicant for G7, Dental Operative Unit and Accessories?

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

What is the FDA product code for G7, Dental Operative Unit and Accessories?

The FDA product code for G7, Dental Operative Unit and Accessories is EIA.

其他以 Shinhung Company, Ltd. 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。

K151996泰魯斯C1

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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