SunCHECK
K号: K170307 · 2017-10-25
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器械摘要
SunCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corporation. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K170307. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SunCHECK?
SunCHECK is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K170307.
When did SunCHECK receive FDA 510(k) clearance?
SunCHECK received FDA 510(k) clearance on 2017-10-25, under 510(k) number K170307.
Who is the listed applicant for SunCHECK?
The FDA 510(k) record lists Sun Nuclear Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SunCHECK?
The FDA product code for SunCHECK is IYE.
相关临床试验
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列明Sun Nuclear Corporation为申报人的其他记录
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相关器械（代码：IYE）
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。
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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