FDA 510(k)

真空輸送空氣/水壓瓶管

K 號：K191366 · 2019-09-06

決定日期2019-09-06

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 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 2019-09-06 under 510(k) number K191366. 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 Air/Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K191366.

When did Vacutore Air/Water Bottle Tubing receive FDA 510(k) clearance?

Vacutore Air/Water Bottle Tubing received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191366.

Who is the listed applicant for Vacutore Air/Water Bottle Tubing?

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 Vacutore Air/Water Bottle Tubing?

The FDA product code for Vacutore Air/Water Bottle Tubing is OCX.

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。

K191231Andorate 辅助水連接器，Andorate 阀門組 K182998Andorate 辅助水連接器 K181509Endorate 過濾器組

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。

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官方來源

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