DuoFLEX 线圈套件
K号: K173290 · 2017-11-28
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器械摘要
DuoFLEX Coil Suite is the device name listed in this FDA 510(k) record. The listed applicant is Mr Instruments, Inc.. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K173290. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DuoFLEX Coil Suite?
DuoFLEX Coil Suite is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Mr Instruments, Inc.. The 510(k) number is K173290.
When did DuoFLEX Coil Suite receive FDA 510(k) clearance?
DuoFLEX Coil Suite received FDA 510(k) clearance on 2017-11-28, under 510(k) number K173290.
Who is the listed applicant for DuoFLEX Coil Suite?
The FDA 510(k) record lists Mr Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DuoFLEX Coil Suite?
The FDA product code for DuoFLEX Coil Suite is MOS.
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。
相关器械（代码：MOS）
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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