Aimanfun Lumea Comfort, A-2789/A-3588
K号: K212907 · 2021-12-02
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决定日期2021-12-02
产品代码ONF
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, A-2789/A-3588 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 2021-12-02 under 510(k) number K212907. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aimanfun Lumea Comfort, A-2789/A-3588?
Aimanfun Lumea Comfort, A-2789/A-3588 is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K212907.
When did Aimanfun Lumea Comfort, A-2789/A-3588 receive FDA 510(k) clearance?
Aimanfun Lumea Comfort, A-2789/A-3588 received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212907.
Who is the listed applicant for Aimanfun Lumea Comfort, A-2789/A-3588?
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, A-2789/A-3588?
The FDA product code for Aimanfun Lumea Comfort, A-2789/A-3588 is ONF.
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：ONF）
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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