FDA 510(k)

NxStage PureFlow Solution

K番号: K233213 · 2024-01-18

決定日2024-01-18

製品コードKPO

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

申請者としてNxstage Medical, Inc.を記載するその他の記録

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K230632VersiHD with GuideMe software K183158NxStage Cartridge Express with Speedswap K181991NxStage Connected Health System K171331NxStage System One K170469NxStage System One Plus

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