婴儿培养箱
K号: K190494 · 2019-11-25
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决定日期2019-11-25
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
Infant Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo David Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K190494. 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 Infant Incubator?
Infant Incubator is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Ningbo David Medical Device Co., Ltd.. The 510(k) number is K190494.
When did Infant Incubator receive FDA 510(k) clearance?
Infant Incubator received FDA 510(k) clearance on 2019-11-25, under 510(k) number K190494.
Who is the listed applicant for Infant Incubator?
The FDA 510(k) record lists Ningbo David Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infant Incubator?
The FDA product code for Infant Incubator is FMZ.
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。
相关器械（代码：FMZ）
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。
K260326长颈鹿™ 全能床™ 护理站（CS1）；长颈鹿™ 婴儿培养箱护理站（CS1）Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed 护理站 (CS1)；Giraffe 孵化器护理站 (CS1)Datex-Ohmeda, Inc.K243437mOm 基础型孵化器（ME1）Mom Incubators LimitedK213553Giraffe 孵化器护理站 CS1Datex Ohmeda, Inc.K182859Babyleo TN500Dragerwerk AG & CO Kgaa
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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