SREE MRI 运输孵化器
K号: K161918 · 2017-03-03
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决定日期2017-03-03
产品代码FPL
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。
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器械摘要
SREE MRI Transport Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Imaging Research Dba Sree Medical Systems. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K161918. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SREE MRI Transport Incubator?
SREE MRI Transport Incubator is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Advanced Imaging Research Dba Sree Medical Systems. The 510(k) number is K161918.
When did SREE MRI Transport Incubator receive FDA 510(k) clearance?
SREE MRI Transport Incubator received FDA 510(k) clearance on 2017-03-03, under 510(k) number K161918.
Who is the listed applicant for SREE MRI Transport Incubator?
The FDA 510(k) record lists Advanced Imaging Research Dba Sree Medical Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SREE MRI Transport Incubator?
The FDA product code for SREE MRI Transport Incubator is FPL.
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：FPL）
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。
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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