LED面部遮光仪
K号: K230351 · 2023-05-05
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决定日期2023-05-05
产品代码OHS
咨询委员会SU
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决定实质等同
器械摘要
LED Facial Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K230351. 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 LED Facial Mask?
LED Facial Mask is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.. The 510(k) number is K230351.
When did LED Facial Mask receive FDA 510(k) clearance?
LED Facial Mask received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230351.
Who is the listed applicant for LED Facial Mask?
The FDA 510(k) record lists Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LED Facial Mask?
The FDA product code for LED Facial Mask 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
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