医疗口罩，型号名称：MY020003
K号: K211165 · 2021-11-09
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决定日期2021-11-09
产品代码FXX
咨询委员会SU
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决定实质等同
器械摘要
Medical Face Masks, Model Name:MY020003 is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211165. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Medical Face Masks, Model Name:MY020003?
Medical Face Masks, Model Name:MY020003 is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. The 510(k) number is K211165.
When did Medical Face Masks, Model Name:MY020003 receive FDA 510(k) clearance?
Medical Face Masks, Model Name:MY020003 received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211165.
Who is the listed applicant for Medical Face Masks, Model Name:MY020003?
The FDA 510(k) record lists Huizhou Jie Bai Purification Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Face Masks, Model Name:MY020003?
The FDA product code for Medical Face Masks, Model Name:MY020003 is FXX.
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。
相关器械（代码：FXX）
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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