维纳斯传奇Pro设备
K号: K191528 · 2019-09-06
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决定日期2019-09-06
产品代码GEI
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Venus Legacy Pro Device is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191528. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Venus Legacy Pro Device?
Venus Legacy Pro Device is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K191528.
When did Venus Legacy Pro Device receive FDA 510(k) clearance?
Venus Legacy Pro Device received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191528.
Who is the listed applicant for Venus Legacy Pro Device?
The FDA 510(k) record lists Venus Concept USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Venus Legacy Pro Device?
The FDA product code for Venus Legacy Pro Device is GEI.
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Venus Concept USA, Inc.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：GEI）
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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