MRIaudio PREM系统带MRIview
K号: K193102 · 2020-01-06
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器械摘要
MRIaudio PREM System with MRIview is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio, Inc.. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K193102. 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 with MRIview?
MRIaudio PREM System with MRIview is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Mriaudio, Inc.. The 510(k) number is K193102.
When did MRIaudio PREM System with MRIview receive FDA 510(k) clearance?
MRIaudio PREM System with MRIview received FDA 510(k) clearance on 2020-01-06, under 510(k) number K193102.
Who is the listed applicant for MRIaudio PREM System with MRIview?
The FDA 510(k) record lists Mriaudio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRIaudio PREM System with MRIview?
The FDA product code for MRIaudio PREM System with MRIview 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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