BlueCheck™ 龋齿检测与监测
K号: K222560 · 2023-05-16
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决定日期2023-05-16
产品代码LFC
咨询委员会DE
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决定实质等同
器械摘要
BlueCheck™ Caries Detection & Monitoring is the device name listed in this FDA 510(k) record. The listed applicant is Incisive Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222560. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BlueCheck™ Caries Detection & Monitoring?
BlueCheck™ Caries Detection & Monitoring is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Incisive Technologies Pty, Ltd.. The 510(k) number is K222560.
When did BlueCheck™ Caries Detection & Monitoring receive FDA 510(k) clearance?
BlueCheck™ Caries Detection & Monitoring received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222560.
Who is the listed applicant for BlueCheck™ Caries Detection & Monitoring?
The FDA 510(k) record lists Incisive Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BlueCheck™ Caries Detection & Monitoring?
The FDA product code for BlueCheck™ Caries Detection & Monitoring is LFC.
相关临床试验
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相关器械（代码：LFC）
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。
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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