Z5-BL
K号: K200386 · 2020-10-14
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申请人Z-Systems AG
决定日期2020-10-14
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
Z5-BL is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2020-10-14 under 510(k) number K200386. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Z5-BL?
Z5-BL is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Z-Systems AG. The 510(k) number is K200386.
When did Z5-BL receive FDA 510(k) clearance?
Z5-BL received FDA 510(k) clearance on 2020-10-14, under 510(k) number K200386.
Who is the listed applicant for Z5-BL?
The FDA 510(k) record lists Z-Systems AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Z5-BL?
The FDA product code for Z5-BL is DZE.
列明Z-Systems AG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：DZE）
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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