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FDA 510(k)

牙科影像板掃描儀，型號DFC-4T-SMART

K 號：K214091 · 2022-03-02

申請人Hefei Dentafilm Medical Equipment Co., Ltd.
決定日期2022-03-02
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

Dental Image Plate Scanner, Model DFC-4T-SMART is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K214091. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental Image Plate Scanner, Model DFC-4T-SMART?

Dental Image Plate Scanner, Model DFC-4T-SMART is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. The 510(k) number is K214091.

When did Dental Image Plate Scanner, Model DFC-4T-SMART receive FDA 510(k) clearance?

Dental Image Plate Scanner, Model DFC-4T-SMART received FDA 510(k) clearance on 2022-03-02, under 510(k) number K214091.

Who is the listed applicant for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA 510(k) record lists Hefei Dentafilm Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART is MUH.

相關臨床試驗

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：MUH）

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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