FDA 510(k)

Ivenix インフュージョンシステム、LVP エピドゥラル投与セット NRFit コネクタ

K番号: K213089 · 2021-11-10

決定日2021-11-10

製品コードFPA

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Ivenix, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K213089. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Ivenix, Inc.. The 510(k) number is K213089.

When did Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector receive FDA 510(k) clearance?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector received FDA 510(k) clearance on 2021-11-10, under 510(k) number K213089.

Who is the listed applicant for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

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

What is the FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

The FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is FPA.

申請者としてIvenix, Inc.を記載するその他の記録

K183311Ivenix 注射システム（IIS）

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