FDA 510(k)

Insignis™ 靜脈注射系統

K 號：K232328 · 2024-03-01

決定日期2024-03-01

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

Insignis™ Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232328. 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 Insignis™ Syringe Infusion System?

Insignis™ Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K232328.

When did Insignis™ Syringe Infusion System receive FDA 510(k) clearance?

Insignis™ Syringe Infusion System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232328.

Who is the listed applicant for Insignis™ Syringe Infusion System?

The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignis™ Syringe Infusion System?

The FDA product code for Insignis™ Syringe Infusion System is FPA.

其他以 Innovative Health Sciences, LLC 為申請人之記錄

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K202279Insignis 皮下单針組

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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