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FDA 510(k)

內視鏡荧光攝影系統（DPM-ENDOCAM-03PF）

K 號：K233840 · 2024-06-26

申請人Zhuhai Dipu Medical Technology Co., Ltd.
決定日期2024-06-26
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Dipu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K233840. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)?

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Zhuhai Dipu Medical Technology Co., Ltd.. The 510(k) number is K233840.

When did Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) receive FDA 510(k) clearance?

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233840.

Who is the listed applicant for Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)?

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

What is the FDA product code for Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)?

The FDA product code for Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) is GCJ.

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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其他以 Zhuhai Dipu Medical Technology Co., 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。

K2338923D內視鏡荧光攝影系統（DPM-ENDOCAM-06PF）

相關器械（代碼：GCJ）

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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