FDA 510(k)

Giraffe OmniBed 护理站 (CS1)；Giraffe 孵化器护理站 (CS1)

K号: K251663 · 2025-10-22

决定日期2025-10-22

产品代码FMZ

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

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251663. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K251663.

When did Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) receive FDA 510(k) clearance?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251663.

Who is the listed applicant for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

FDA 510(k)记录中列出Datex-Ohmeda, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

The FDA product code for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is FMZ.

列明Datex-Ohmeda, Inc.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。

K254036Novii+ 无线贴片系统 K260326长颈鹿™ 全能床™ 护理站（CS1）；长颈鹿™ 婴儿培养箱护理站（CS1）K213867Carestation 750/750c K213551Giraffe Omnibed 护理站 CS1 K213553Giraffe 孵化器护理站 CS1 K210384CARESCAPE R860

查看所有 11 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。