T-Lite
K号: K201988 · 2020-10-30
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器械摘要
T-Lite is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscanner. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K201988. 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 T-Lite?
T-Lite is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Sonoscanner. The 510(k) number is K201988.
When did T-Lite receive FDA 510(k) clearance?
T-Lite received FDA 510(k) clearance on 2020-10-30, under 510(k) number K201988.
Who is the listed applicant for T-Lite?
The FDA 510(k) record lists Sonoscanner as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T-Lite?
The FDA product code for T-Lite is IYN.
列明Sonoscanner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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