FDA 510(k)

レナピュアエンドトキシン保持フィルタ

K番号: K231410 · 2023-07-19

決定日2023-07-19

製品コードFIP

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

決定大幅同等

医療機器の概要

RenaPure Endotoxin Retentive Filter is the device name listed in this FDA 510(k) record. The listed applicant is Evoqua Water Technologies, LLC. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231410. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the RenaPure Endotoxin Retentive Filter?

RenaPure Endotoxin Retentive Filter is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Evoqua Water Technologies, LLC. The 510(k) number is K231410.

When did RenaPure Endotoxin Retentive Filter receive FDA 510(k) clearance?

RenaPure Endotoxin Retentive Filter received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231410.

Who is the listed applicant for RenaPure Endotoxin Retentive Filter?

The FDA 510(k) record lists Evoqua Water Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RenaPure Endotoxin Retentive Filter?

The FDA product code for RenaPure Endotoxin Retentive Filter is FIP.

申請者としてEvoqua Water Technologies, LLCを記載するその他の記録

K153784NOSOGARD フィルタ

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