i8 美容舱
K号: K210004 · 2021-12-10
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决定日期2021-12-10
产品代码FTC
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
i8 Tanning Booth is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasun International B.V.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K210004. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the i8 Tanning Booth?
i8 Tanning Booth is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Ultrasun International B.V.. The 510(k) number is K210004.
When did i8 Tanning Booth receive FDA 510(k) clearance?
i8 Tanning Booth received FDA 510(k) clearance on 2021-12-10, under 510(k) number K210004.
Who is the listed applicant for i8 Tanning Booth?
The FDA 510(k) record lists Ultrasun International B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i8 Tanning Booth?
The FDA product code for i8 Tanning Booth is FTC.
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：FTC）
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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