无线音频系统
K号: K173409 · 2018-02-16
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器械摘要
Wireless Audio System is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K173409. 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 Wireless Audio System?
Wireless Audio System is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Neocoil, LLC. The 510(k) number is K173409.
When did Wireless Audio System receive FDA 510(k) clearance?
Wireless Audio System received FDA 510(k) clearance on 2018-02-16, under 510(k) number K173409.
Who is the listed applicant for Wireless Audio System?
The FDA 510(k) record lists Neocoil, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wireless Audio System?
The FDA product code for Wireless Audio System 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Neocoil, LLC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。
K2609470.55T 12Ch乳腺线圈K22240716ch 母乳线圈 / 16ch 母乳线圈，1.5T 16ch 母乳线圈，3.0T 16ch 母乳线圈，1.5T 16ch 母乳线圈，3T 16ch 母乳线圈K21368732Ch AIR 开放线圈套件：1.5T AIR 开放头颈后部 9ch / 3.0T AIR 开放头颈后部 9ch，1.5T AIR 开放颈部胸部前部 7ch / 3.0T AIR 开放颈部胸部前部 7ch，1.5T AIR 开放头前部 16ch / 3.0T AIR 开放头前部 16chK2011011.5T 16ch 肩部线圈，3.0T 16ch 肩部线圈K1829581.5T 16ch 乳腺线圈K1733773.0T 16通道乳腺线圈
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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