invisa-RED ELITE
K号: K192275 · 2020-08-19
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决定日期2020-08-19
产品代码OLI
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
invisa-RED ELITE is the device name listed in this FDA 510(k) record. The listed applicant is IR Technology, LLC. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K192275. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the invisa-RED ELITE?
invisa-RED ELITE is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is IR Technology, LLC. The 510(k) number is K192275.
When did invisa-RED ELITE receive FDA 510(k) clearance?
invisa-RED ELITE received FDA 510(k) clearance on 2020-08-19, under 510(k) number K192275.
Who is the listed applicant for invisa-RED ELITE?
The FDA 510(k) record lists IR Technology, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for invisa-RED ELITE?
The FDA product code for invisa-RED ELITE is OLI.
相关临床试验
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相关器械（代码：OLI）
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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