Aimanfun Lumea Comfort
K号: K190820 · 2019-10-02
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决定日期2019-10-02
产品代码OHT
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
Aimanfun Lumea Comfort is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K190820. 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 Aimanfun Lumea Comfort?
Aimanfun Lumea Comfort is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K190820.
When did Aimanfun Lumea Comfort receive FDA 510(k) clearance?
Aimanfun Lumea Comfort received FDA 510(k) clearance on 2019-10-02, under 510(k) number K190820.
Who is the listed applicant for Aimanfun Lumea Comfort?
FDA 510(k)记录将嘉源塑料制品有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Aimanfun Lumea Comfort?
The FDA product code for Aimanfun Lumea Comfort 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Kam Yuen Plastic Products , Ltd.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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