ABL90 FLEX PLUS
K号: K160153 · 2016-11-04
广告
决定日期2016-11-04
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
ABL90 FLEX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160153. 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 ABL90 FLEX PLUS?
ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Radiometer Medical Aps. The 510(k) number is K160153.
When did ABL90 FLEX PLUS receive FDA 510(k) clearance?
ABL90 FLEX PLUS received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160153.
Who is the listed applicant for ABL90 FLEX PLUS?
The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ABL90 FLEX PLUS?
The FDA product code for ABL90 FLEX PLUS is CHL.
列明Radiometer Medical Aps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