BD MAX Check-Points CPO
K号: K190613 · 2019-08-29
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决定日期2019-08-29
产品代码POC
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器械摘要
BD MAX Check-Points CPO is the device name listed in this FDA 510(k) record. The listed applicant is Check-Points Health B.V.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K190613. The device is classified under product code POC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD MAX Check-Points CPO?
BD MAX Check-Points CPO is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Check-Points Health B.V.. The 510(k) number is K190613.
When did BD MAX Check-Points CPO receive FDA 510(k) clearance?
BD MAX Check-Points CPO received FDA 510(k) clearance on 2019-08-29, under 510(k) number K190613.
Who is the listed applicant for BD MAX Check-Points CPO?
The FDA 510(k) record lists Check-Points Health B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD MAX Check-Points CPO?
The FDA product code for BD MAX Check-Points CPO is POC.
相关临床试验
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相关器械（代码：POC）
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。
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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