XV 肺通气分析软件
K号: K193293 · 2020-05-14
广告
器械摘要
XV Lung Ventilation Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is 4Dx Limited. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K193293. 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 XV Lung Ventilation Analysis Software?
XV Lung Ventilation Analysis Software is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is 4Dx Limited. The 510(k) number is K193293.
When did XV Lung Ventilation Analysis Software receive FDA 510(k) clearance?
XV Lung Ventilation Analysis Software received FDA 510(k) clearance on 2020-05-14, under 510(k) number K193293.
Who is the listed applicant for XV Lung Ventilation Analysis Software?
The FDA 510(k) record lists 4Dx Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XV Lung Ventilation Analysis Software?
The FDA product code for XV Lung Ventilation Analysis Software 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。
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