i-CAT FLX V系列 / KaVo 3D eXam+ V系列
K号: K162085 · 2016-11-10
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器械摘要
i-CAT FLX V series / KaVo 3D eXam+ V series is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences International. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162085. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the i-CAT FLX V series / KaVo 3D eXam+ V series?
i-CAT FLX V series / KaVo 3D eXam+ V series is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Imaging Sciences International. The 510(k) number is K162085.
When did i-CAT FLX V series / KaVo 3D eXam+ V series receive FDA 510(k) clearance?
i-CAT FLX V series / KaVo 3D eXam+ V series received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162085.
Who is the listed applicant for i-CAT FLX V series / KaVo 3D eXam+ V series?
The FDA 510(k) record lists Imaging Sciences International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series?
The FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series is OAS.
相关临床试验
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相关器械（代码：OAS）
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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