EVA（增强视觉评估）系统
K号: K161871 · 2016-12-19
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决定日期2016-12-19
产品代码HEX
咨询委员会OB
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决定实质等同
器械摘要
EVA (Enhanced Visual Assessment) System is the device name listed in this FDA 510(k) record. The listed applicant is Mobileodt , Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161871. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EVA (Enhanced Visual Assessment) System?
EVA (Enhanced Visual Assessment) System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Mobileodt , Ltd.. The 510(k) number is K161871.
When did EVA (Enhanced Visual Assessment) System receive FDA 510(k) clearance?
EVA (Enhanced Visual Assessment) System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161871.
Who is the listed applicant for EVA (Enhanced Visual Assessment) System?
The FDA 510(k) record lists Mobileodt , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EVA (Enhanced Visual Assessment) System?
The FDA product code for EVA (Enhanced Visual Assessment) System is HEX.
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相关器械（代码：HEX）
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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