Isolette 8000 plus
K号: K172154 · 2018-04-19
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决定日期2018-04-19
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
Isolette 8000 plus is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Sytems, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172154. 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 Isolette 8000 plus?
Isolette 8000 plus is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Draeger Medical Sytems, Inc.. The 510(k) number is K172154.
When did Isolette 8000 plus receive FDA 510(k) clearance?
Isolette 8000 plus received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172154.
Who is the listed applicant for Isolette 8000 plus?
The FDA 510(k) record lists Draeger Medical Sytems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Isolette 8000 plus?
The FDA product code for Isolette 8000 plus is FMZ.
相关临床试验
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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。
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官方来源
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