LEONI ORION 系统
K号: K160518 · 2016-07-14
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器械摘要
LEONI ORION System is the device name listed in this FDA 510(k) record. The listed applicant is Leoni Cia Cable System. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160518. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LEONI ORION System?
LEONI ORION System is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Leoni Cia Cable System. The 510(k) number is K160518.
When did LEONI ORION System receive FDA 510(k) clearance?
LEONI ORION System received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160518.
Who is the listed applicant for LEONI ORION System?
The FDA 510(k) record lists Leoni Cia Cable System as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LEONI ORION System?
The FDA product code for LEONI ORION System is JAI.
相关临床试验
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相关器械（代码：JAI）
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。
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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