FDA 510(k)

單次使用內視鏡閥門組

K 號：K192048 · 2020-05-14

決定日期2020-05-14

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Single Use Endoscope Valves Set is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K192048. 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 Single Use Endoscope Valves Set?

Single Use Endoscope Valves Set is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K192048.

When did Single Use Endoscope Valves Set receive FDA 510(k) clearance?

Single Use Endoscope Valves Set received FDA 510(k) clearance on 2020-05-14, under 510(k) number K192048.

Who is the listed applicant for Single Use Endoscope Valves Set?

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

What is the FDA product code for Single Use Endoscope Valves Set?

The FDA product code for Single Use Endoscope Valves Set is ODC.

其他以 Anrei Medical (Hangzhou) 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。

K212999多功能電外科刀 K210917單次使用注射針 K202987救援肺抓取镊子 K210660石子回收氣球導管 K201771單次使用可旋轉及可重置式血液夾

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。