FDA 510(k)

SIGMA Spectrum 输液泵带主药物库

K号: K251640 · 2025-07-28

决定日期2025-07-28

产品代码FRN

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

SIGMA Spectrum Infusion Pump with Master Drug Library 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 K251640. 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 SIGMA Spectrum Infusion Pump with Master Drug Library?

SIGMA Spectrum Infusion Pump with Master Drug Library 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 K251640.

When did SIGMA Spectrum Infusion Pump with Master Drug Library receive FDA 510(k) clearance?

SIGMA Spectrum Infusion Pump with Master Drug Library received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251640.

Who is the listed applicant for SIGMA Spectrum Infusion Pump with Master Drug Library?

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 SIGMA Spectrum Infusion Pump with Master Drug Library?

The FDA product code for SIGMA Spectrum Infusion Pump with Master Drug Library 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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