FDA 510(k)

Andorate 辅助水連接器

K 號：K182998 · 2019-04-17

決定日期2019-04-17

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Andorate Auxiliary Water Connector 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 2019-04-17 under 510(k) number K182998. 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 Andorate Auxiliary Water Connector?

Andorate Auxiliary Water Connector is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K182998.

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

Andorate Auxiliary Water Connector received FDA 510(k) clearance on 2019-04-17, under 510(k) number K182998.

Who is the listed applicant for Andorate Auxiliary Water Connector?

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?

The FDA product code for Andorate Auxiliary Water Connector 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。

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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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