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FDA 510(k)

肯特攝影機

K 號:K163070 · 2017-05-05

決定日期2017-05-05
產品代碼MUD
諮詢委員會履歷
決定相當於

器材摘要

Kent Camera is the device name listed in this FDA 510(k) record. The listed applicant is Kent Imaging, Inc.. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K163070. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kent Camera?

Kent Camera is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Kent Imaging, Inc.. The 510(k) number is K163070.

When did Kent Camera receive FDA 510(k) clearance?

Kent Camera received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163070.

Who is the listed applicant for Kent Camera?

The FDA 510(k) record lists Kent Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kent Camera?

The FDA product code for Kent Camera is MUD.

相關臨床試驗

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其他以 Kent Imaging, Inc. 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。

相關器械(代碼:MUD)

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。

官方來源

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