SmoothSkin BARE+
K号: K192010 · 2019-09-24
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器械摘要
SmoothSkin BARE+ is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K192010. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmoothSkin BARE+?
SmoothSkin BARE+ is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Cyden Limited. The 510(k) number is K192010.
When did SmoothSkin BARE+ receive FDA 510(k) clearance?
SmoothSkin BARE+ received FDA 510(k) clearance on 2019-09-24, under 510(k) number K192010.
Who is the listed applicant for SmoothSkin BARE+?
FDA 510(k)记录显示Cyden Limited为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for SmoothSkin BARE+?
The FDA product code for SmoothSkin BARE+ is OHT.
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Cyden Limited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：OHT）
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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