FDA 510(k)

Novum IQ 輸液泵 (40800BAXUS)

K 號：K242390 · 2024-09-05

決定日期2024-09-05

產品代碼FRN

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

Novum IQ Syringe Pump (40800BAXUS) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K242390. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Novum IQ Syringe Pump (40800BAXUS)?

Novum IQ Syringe Pump (40800BAXUS) is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K242390.

When did Novum IQ Syringe Pump (40800BAXUS) receive FDA 510(k) clearance?

Novum IQ Syringe Pump (40800BAXUS) received FDA 510(k) clearance on 2024-09-05, under 510(k) number K242390.

Who is the listed applicant for Novum IQ Syringe Pump (40800BAXUS)?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Novum IQ Syringe Pump (40800BAXUS)?

The FDA product code for Novum IQ Syringe Pump (40800BAXUS) is FRN.

其他以 Baxter Healthcare Corporation 為申請人之記錄

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相關器械（代碼：FRN）

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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