FDA 510(k)

一次性內視鏡閥門組

K 號：K250732 · 2025-06-20

申請人Yangzhou Fartley Medical Instrument Technology Co., Ltd.

決定日期2025-06-20

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Disposable Endoscopy Valve Set is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250732. 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 Endoscopy Valve Set?

Disposable Endoscopy Valve Set is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K250732.

When did Disposable Endoscopy Valve Set receive FDA 510(k) clearance?

Disposable Endoscopy Valve Set received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250732.

Who is the listed applicant for Disposable Endoscopy Valve Set?

FDA 510(k) 記錄將揚州法爾蒂醫療儀器技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Disposable Endoscopy Valve Set?

The FDA product code for Disposable Endoscopy Valve Set is ODC.

其他以 Yangzhou Fartley Medical Instrument 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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