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FDA 510(k)

Homechoice Claria APD 系統，與 Homechoice Claria APD 系統搭配使用的 Sharesource 連接平台

K 號：K201867 · 2020-11-19

申請人Baxter Healthcare Corporation
決定日期2020-11-19
產品代碼FKX
諮詢委員會GU
決定相當於

器材摘要

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K201867. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K201867.

When did Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System receive FDA 510(k) clearance?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System received FDA 510(k) clearance on 2020-11-19, under 510(k) number K201867.

Who is the listed applicant for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

The FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is FKX.

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其他以 Baxter Healthcare Corporation 為申請人之記錄

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相關器械（代碼：FKX）

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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