FDA 510(k)

Spectrum IQ 注射系统，配备剂量 IQ 安全软件（3570009）

K号: K251636 · 2025-07-28

决定日期2025-07-28

产品代码FRN

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决定实质等同

器械摘要

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) 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 2025-07-28 under 510(k) number K251636. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K251636.

When did Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) receive FDA 510(k) clearance?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251636.

Who is the listed applicant for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

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 Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

The FDA product code for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is FRN.

列明Baxter Healthcare Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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