epoc 血液分析系统
K号: K200107 · 2020-06-05
广告
申请人Epocal, Inc.
决定日期2020-06-05
产品代码CHL
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
epoc Blood Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K200107. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the epoc Blood Analysis System?
epoc Blood Analysis System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Epocal, Inc.. The 510(k) number is K200107.
When did epoc Blood Analysis System receive FDA 510(k) clearance?
epoc Blood Analysis System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K200107.
Who is the listed applicant for epoc Blood Analysis System?
The FDA 510(k) record lists Epocal, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for epoc Blood Analysis System?
The FDA product code for epoc Blood Analysis System is CHL.
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Epocal, Inc.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：CHL）
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。
K252207ABL90 FLEX PLUS 系统，safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ 芯片，适用于 i-STAT 1 系统Abbott Point of Care, Inc.K240998ABL90 FLEX PLUS 系统Radiometer Medicals ApsK230285i-STAT CG8+ 芯片，适用于 i-STAT 1 系统Abbott Point of Care, Inc.K221900Stat Profile Prime Plus分析系统Nova Biomedical CorporationK223857i-STAT G3+ 芯片与i-STAT 1 系统Abbott Point of Care, Inc.
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