CAS-One IR
K号: K152473 · 2016-01-20
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器械摘要
CAS-One IR is the device name listed in this FDA 510(k) record. The listed applicant is Cascination AG. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152473. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CAS-One IR?
CAS-One IR is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Cascination AG. The 510(k) number is K152473.
When did CAS-One IR receive FDA 510(k) clearance?
CAS-One IR received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152473.
Who is the listed applicant for CAS-One IR?
The FDA 510(k) record lists Cascination AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CAS-One IR?
The FDA product code for CAS-One IR is JAK.
列明Cascination 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：JAK）
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
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