MRIaudio PREM系统
K号: K180100 · 2018-06-14
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器械摘要
MRIaudio PREM System is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180100. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MRIaudio PREM System?
MRIaudio PREM System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Mriaudio. The 510(k) number is K180100.
When did MRIaudio PREM System receive FDA 510(k) clearance?
MRIaudio PREM System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180100.
Who is the listed applicant for MRIaudio PREM System?
The FDA 510(k) record lists Mriaudio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRIaudio PREM System?
The FDA product code for MRIaudio PREM System is LNH.
相关临床试验
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相关器械（代码：LNH）
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
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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