TwitchView系统
K号: K192958 · 2020-04-02
广告
决定日期2020-04-02
产品代码KOI
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
TwitchView System is the device name listed in this FDA 510(k) record. The listed applicant is Blink Device Company. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K192958. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TwitchView System?
TwitchView System is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Blink Device Company. The 510(k) number is K192958.
When did TwitchView System receive FDA 510(k) clearance?
TwitchView System received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192958.
Who is the listed applicant for TwitchView System?
The FDA 510(k) record lists Blink Device Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TwitchView System?
The FDA product code for TwitchView System is KOI.
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：KOI）
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。
K261098TetraGraph神经肌肉传导监测器（SEN 2015）配件：TetraSens（SEN 2012）TetraSens儿童（SEN 2013）TetraSensitive（SEN 2016）TetraHub（SEN 2017）Senzime ABK250887神经肌肉传导监测器TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph神经肌肉传导监测器Senzime ABK220976Life Scope PT BSM-1700系列床旁监护仪Nihon Kohden 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。
广告