我的LED面罩
K号: K223147 · 2023-05-14
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器械摘要
myLEDmask is the device name listed in this FDA 510(k) record. The listed applicant is Myblend. It received FDA 510(k) clearance on 2023-05-14 under 510(k) number K223147. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the myLEDmask?
myLEDmask is a medical device that received FDA 510(k) clearance on 2023-05-14. The listed applicant is Myblend. The 510(k) number is K223147.
When did myLEDmask receive FDA 510(k) clearance?
myLEDmask received FDA 510(k) clearance on 2023-05-14, under 510(k) number K223147.
Who is the listed applicant for myLEDmask?
The FDA 510(k) record lists Myblend as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for myLEDmask?
The FDA product code for myLEDmask is OHS.
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：OHS）
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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