Cruxcan (CRX-1000)
K号: K183637 · 2019-02-12
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决定日期2019-02-12
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
Cruxcan (CRX-1000) is the device name listed in this FDA 510(k) record. The listed applicant is Cruxell Corp.. It received FDA 510(k) clearance on 2019-02-12 under 510(k) number K183637. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cruxcan (CRX-1000)?
Cruxcan (CRX-1000) is a medical device that received FDA 510(k) clearance on 2019-02-12. The listed applicant is Cruxell Corp.. The 510(k) number is K183637.
When did Cruxcan (CRX-1000) receive FDA 510(k) clearance?
Cruxcan (CRX-1000) received FDA 510(k) clearance on 2019-02-12, under 510(k) number K183637.
Who is the listed applicant for Cruxcan (CRX-1000)?
The FDA 510(k) record lists Cruxell Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cruxcan (CRX-1000)?
The FDA product code for Cruxcan (CRX-1000) is MUH.
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Cruxell Corp.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：MUH）
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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