FDA 510(k)

一次性內視鏡閥門組套

K 號：K222499 · 2023-11-22

申請人Shanghai SeeGen Photoelectric Technology Co., Ltd.

決定日期2023-11-22

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Disposable Endoscope Valves Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K222499. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Endoscope Valves Kit?

Disposable Endoscope Valves Kit is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222499.

When did Disposable Endoscope Valves Kit receive FDA 510(k) clearance?

Disposable Endoscope Valves Kit received FDA 510(k) clearance on 2023-11-22, under 510(k) number K222499.

Who is the listed applicant for Disposable Endoscope Valves Kit?

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

What is the FDA product code for Disposable Endoscope Valves Kit?

The FDA product code for Disposable Endoscope Valves Kit is ODC.

其他以 Shanghai SeeGen Photoelectric Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：ODC）

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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