FDA 510(k)

潘太克斯醫療閥門組合

K 號：K222980 · 2022-11-21

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

決定日期2022-11-21

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Pentax Medical 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 2022-11-21 under 510(k) number K222980. 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 Pentax Medical Valve Set?

Pentax Medical Valve Set is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K222980.

When did Pentax Medical Valve Set receive FDA 510(k) clearance?

Pentax Medical Valve Set received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222980.

Who is the listed applicant for Pentax Medical 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 Pentax Medical Valve Set?

The FDA product code for Pentax Medical Valve Set is ODC.

其他以 Yangzhou Fartley Medical Instrument 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。

K260512一次性輸尿管進入鞘 K260423一次性內視鏡遠端附件 K250732一次性內視鏡閥門組 K230004一次性血夾 K220785清潔連接管 K220292一次性內視鏡注射針

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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。

K252933DYNE PORTDyne Medical Group, Inc.K250145組織切片端口轉接器Endosound, Inc.K252910Orca 空氣/水及吸引閥Boston Scientific K250949吸引閥 (MAJ-1443)；空氣/水閥 (MAJ-1444)Olympus Medical Systems Corporation K250732一次性內視鏡閥門組Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842路氏分離 MAJ-2092Olympus Medical Systems Corporation

官方來源

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