X-MIND 三维
K号: K160166 · 2016-11-15
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器械摘要
X-MIND trium is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160166. 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 X-MIND trium?
X-MIND trium is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K160166.
When did X-MIND trium receive FDA 510(k) clearance?
X-MIND trium received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160166.
Who is the listed applicant for X-MIND trium?
The FDA 510(k) record lists De Gotzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-MIND trium?
The FDA product code for X-MIND trium is OAS.
相关临床试验
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。
列明De Gotzen S.R.L.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：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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