FDA 510(k)

Andorate 辅助水連接器，Andorate 阀門組

K 號：K191231 · 2019-06-07

決定日期2019-06-07

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Andorate Auxiliary Water Connector, Andorate Valves Set is the device name listed in this FDA 510(k) record. The listed applicant is Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K191231. 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 Andorate Auxiliary Water Connector, Andorate Valves Set?

Andorate Auxiliary Water Connector, Andorate Valves Set is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K191231.

When did Andorate Auxiliary Water Connector, Andorate Valves Set receive FDA 510(k) clearance?

Andorate Auxiliary Water Connector, Andorate Valves Set received FDA 510(k) clearance on 2019-06-07, under 510(k) number K191231.

Who is the listed applicant for Andorate Auxiliary Water Connector, Andorate Valves Set?

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

What is the FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set?

The FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set is ODC.

其他以 Smartdata Suzhou 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。

K191366真空輸送空氣/水壓瓶管 K182998Andorate 辅助水連接器 K181509Endorate 過濾器組

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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