CoreLite X射线标本柜
K号: K193317 · 2019-12-13
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器械摘要
CoreLite X-Ray Specimen Cabinet is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193317. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CoreLite X-Ray Specimen Cabinet?
CoreLite X-Ray Specimen Cabinet is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Cirdan Imaging Limited. The 510(k) number is K193317.
When did CoreLite X-Ray Specimen Cabinet receive FDA 510(k) clearance?
CoreLite X-Ray Specimen Cabinet received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193317.
Who is the listed applicant for CoreLite X-Ray Specimen Cabinet?
The FDA 510(k) record lists Cirdan Imaging Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoreLite X-Ray Specimen Cabinet?
The FDA product code for CoreLite X-Ray Specimen Cabinet is MWP.
相关临床试验
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相关器械（代码：MWP）
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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