FDA 510(k)

NxStage PureFlow 解決方案

K 號：K233213 · 2024-01-18

決定日期2024-01-18

產品代碼KPO

諮詢委員會GU

決定相當於

器材摘要

NxStage PureFlow Solution is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K233213. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NxStage PureFlow Solution?

NxStage PureFlow Solution is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K233213.

When did NxStage PureFlow Solution receive FDA 510(k) clearance?

NxStage PureFlow Solution received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233213.

Who is the listed applicant for NxStage PureFlow Solution?

The FDA 510(k) record lists Nxstage Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NxStage PureFlow Solution?

The FDA product code for NxStage PureFlow Solution is KPO.

其他以 Nxstage Medical, Inc. 為申請人之記錄

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相關器械（代碼：KPO）

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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