FDA 510(k)

Ivenix 注射系統，LVP 骶管注射套件 NRFit 接頭

K 號：K213089 · 2021-11-10

決定日期2021-11-10

產品代碼FPA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Ivenix, Inc. 為申請人之記錄

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K183311Ivenix 注射系統 (IIS)

相關器械（代碼：FPA）

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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官方來源

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