bk2300
K号: K161960 · 2016-10-17
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器械摘要
bk2300 is the device name listed in this FDA 510(k) record. The listed applicant is Bk Medical Aps. It received FDA 510(k) clearance on 2016-10-17 under 510(k) number K161960. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the bk2300?
bk2300 is a medical device that received FDA 510(k) clearance on 2016-10-17. The listed applicant is Bk Medical Aps. The 510(k) number is K161960.
When did bk2300 receive FDA 510(k) clearance?
bk2300 received FDA 510(k) clearance on 2016-10-17, under 510(k) number K161960.
Who is the listed applicant for bk2300?
The FDA 510(k) record lists Bk Medical Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for bk2300?
The FDA product code for bk2300 is IYN.
列明Bk Medical Aps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：IYN）
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。
K263182EVO X30 诊断超声系统；EVO X20 诊断超声系统；EVO X10 诊断超声系统；EVO XP30 诊断超声系统；EVO XP20 诊断超声系统；EVO XP10 诊断超声系统；EVO XC30 诊断超声系统；EVO XC20 诊断超声系统；EVO XC10 诊断超声系统Samsung Medison Co., Ltd.K262548EPIQ Inspira系列诊断超声系统；Affiniti系列诊断超声系统Philips Ultrasound, LLCK261313Vivid 探索者/Vivid 高级/Vivid 焦点GE Medical Systems Ultrasound and Primary Care DiagnosticsK254027数字彩色多普勒超声系统（Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90）Sonoscape Medical Corp.K261668场所：GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion系列诊断超声系统Philips Ultrasound, LLC
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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