C-CAT 麻醉导管套装
K号: K191470 · 2019-10-25
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申请人Cimpax Aps
决定日期2019-10-25
产品代码BSO
咨询委员会AN
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决定实质等同
器械摘要
C-CAT Anaesthesia Catheter kit is the device name listed in this FDA 510(k) record. The listed applicant is Cimpax Aps. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191470. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the C-CAT Anaesthesia Catheter kit?
C-CAT Anaesthesia Catheter kit is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Cimpax Aps. The 510(k) number is K191470.
When did C-CAT Anaesthesia Catheter kit receive FDA 510(k) clearance?
C-CAT Anaesthesia Catheter kit received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191470.
Who is the listed applicant for C-CAT Anaesthesia Catheter kit?
The FDA 510(k) record lists Cimpax Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C-CAT Anaesthesia Catheter kit?
The FDA product code for C-CAT Anaesthesia Catheter kit is BSO.
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。
相关器械（代码：BSO）
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。
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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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