FDA 510(k)

真空輸送空氣/水壓瓶管，真空輸送二氧化碳管路配盧爾接頭

K 號：K200388 · 2020-04-14

決定日期2020-04-14

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K200388. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Ga Health Company Limited. The 510(k) number is K200388.

When did Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector receive FDA 510(k) clearance?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector received FDA 510(k) clearance on 2020-04-14, under 510(k) number K200388.

Who is the listed applicant for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is OCX.

其他以 Ga Health Company Limited 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。

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相關器械（代碼：OCX）

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。

K251986輔助水管 MAJ-855Olympus Medical Systems Corporation K251997單次使用病理切片閥 (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704內視鏡式水泵Hangzhou AGS MedTech Co., Ltd.K242357水壺（MAJ-901）；水壺（MAJ-902）Olympus Medical Systems Corporation K241874吸引針 (2189)Hobbs Medical, Inc.

官方來源

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