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FDA 510(k)

NxStage 開放健康系統

K 號：K181991 · 2018-09-26

申請人Nxstage Medical, Inc.
決定日期2018-09-26
產品代碼FKP
諮詢委員會GU
決定相當於

器材摘要

NxStage Connected Health System 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 2018-09-26 under 510(k) number K181991. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NxStage Connected Health System?

NxStage Connected Health System is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K181991.

When did NxStage Connected Health System receive FDA 510(k) clearance?

NxStage Connected Health System received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181991.

Who is the listed applicant for NxStage Connected Health System?

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 Connected Health System?

The FDA product code for NxStage Connected Health System is FKP.

相關臨床試驗

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其他以 Nxstage Medical, Inc. 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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