AMRA 分析仪
K号: K211983 · 2021-11-24
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器械摘要
AMRA Profiler is the device name listed in this FDA 510(k) record. The listed applicant is Amra Medical AB. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211983. 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 AMRA Profiler?
AMRA Profiler is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Amra Medical AB. The 510(k) number is K211983.
When did AMRA Profiler receive FDA 510(k) clearance?
AMRA Profiler received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211983.
Who is the listed applicant for AMRA Profiler?
The FDA 510(k) record lists Amra Medical AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AMRA Profiler?
The FDA product code for AMRA Profiler is LNH.
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。
列明Amra Medical AB为申报人的其他记录
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：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。
K261283APERTO 明亮 MRI 系统Fujifilm CorporationK261758拥抱愿景新生儿MRI系统Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 便携式MR成像® 系统Hyperfine, Inc.K254250MagicScan-1.5，GreenMR宁静1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems
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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