EasyStat 300
K号: K211559 · 2023-01-27
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决定日期2023-01-27
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
EasyStat 300 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corporation. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K211559. 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 EasyStat 300?
EasyStat 300 is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Medica Corporation. The 510(k) number is K211559.
When did EasyStat 300 receive FDA 510(k) clearance?
EasyStat 300 received FDA 510(k) clearance on 2023-01-27, under 510(k) number K211559.
Who is the listed applicant for EasyStat 300?
The FDA 510(k) record lists Medica Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EasyStat 300?
The FDA product code for EasyStat 300 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Medica Corporation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。
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