Revolution ACT
K号: K171013 · 2017-06-05
广告
器械摘要
Revolution ACT is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-06-05 under 510(k) number K171013. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Revolution ACT?
Revolution ACT is a medical device that received FDA 510(k) clearance on 2017-06-05. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K171013.
When did Revolution ACT receive FDA 510(k) clearance?
Revolution ACT received FDA 510(k) clearance on 2017-06-05, under 510(k) number K171013.
Who is the listed applicant for Revolution ACT?
The FDA 510(k) record lists Ge Hangwei Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Revolution ACT?
The FDA product code for Revolution ACT is JAK.
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Ge Hangwei Medical Systems Co., Ltd.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：JAK）
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。
K261125BodyTom 64（NL4100）；OmniTom Elite（NL5000）Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 视觉阶段 6.0Fujifilm CorporationK253836FCT iStream 阶段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ 套件GE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, 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。
广告