CereFlow™ V1.2
K号: K211059 · 2023-03-31
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器械摘要
CereFlow™ V1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Translational Mri, LLC. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K211059. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CereFlow™ V1.2?
CereFlow™ V1.2 is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Translational Mri, LLC. The 510(k) number is K211059.
When did CereFlow™ V1.2 receive FDA 510(k) clearance?
CereFlow™ V1.2 received FDA 510(k) clearance on 2023-03-31, under 510(k) number K211059.
Who is the listed applicant for CereFlow™ V1.2?
The FDA 510(k) record lists Translational Mri, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CereFlow™ V1.2?
The FDA product code for CereFlow™ V1.2 is LLZ.
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相关器械(代码:LLZ)
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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