Panda iRes Warmer，长颈鹿加热器
K号: K201628 · 2021-02-12
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决定日期2021-02-12
产品代码FMT
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
Panda iRes Warmer, Giraffe Warmer is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K201628. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Panda iRes Warmer, Giraffe Warmer?
Panda iRes Warmer, Giraffe Warmer is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is GE Healthcare. The 510(k) number is K201628.
When did Panda iRes Warmer, Giraffe Warmer receive FDA 510(k) clearance?
Panda iRes Warmer, Giraffe Warmer received FDA 510(k) clearance on 2021-02-12, under 510(k) number K201628.
Who is the listed applicant for Panda iRes Warmer, Giraffe Warmer?
The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Panda iRes Warmer, Giraffe Warmer?
The FDA product code for Panda iRes Warmer, Giraffe Warmer is FMT.
相关临床试验
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。
列明GE Healthcare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。
相关器械（代码：FMT）
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。
K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed 护理站 CS1Datex Ohmeda, Inc.K200319HYDRO-TEMP新生儿皮肤表面温度传感器，HYDRO-TEMP新生儿皮肤表面温度传感器带接口线Deroyal Industries, Inc.K191425Hydro-Temp 新生儿皮肤温度探头盖Deroyal Industries, Inc.K173516NuBorne 婴儿保暖器International Biomedical
官方来源
在 FDA 数据库中查看 →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。
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