Nio Fusion 12MP（MDNC-12130）
K号: K203106 · 2020-11-10
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器械摘要
Nio Fusion 12MP (MDNC-12130) is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2020-11-10 under 510(k) number K203106. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Nio Fusion 12MP (MDNC-12130)?
Nio Fusion 12MP (MDNC-12130) is a medical device that received FDA 510(k) clearance on 2020-11-10. The listed applicant is Barco N.V.. The 510(k) number is K203106.
When did Nio Fusion 12MP (MDNC-12130) receive FDA 510(k) clearance?
Nio Fusion 12MP (MDNC-12130) received FDA 510(k) clearance on 2020-11-10, under 510(k) number K203106.
Who is the listed applicant for Nio Fusion 12MP (MDNC-12130)?
The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nio Fusion 12MP (MDNC-12130)?
The FDA product code for Nio Fusion 12MP (MDNC-12130) is PGY.
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Barco N.V.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：PGY）
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。
K262783RadiForce MX247WEizo CorporationK261213医用监护仪（40HT513D）Lg Electronics.IncK252780LCD 显示器 (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD 显示器 (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo Corporation
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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