LightLas图案扫描系统 - TruScan Pro
K号: K190448 · 2019-05-24
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决定日期2019-05-24
产品代码HQF
咨询委员会OP
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决定实质等同
器械摘要
LightLas Pattern Scanning System - TruScan Pro is the device name listed in this FDA 510(k) record. The listed applicant is Light-Med(Usa), Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190448. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LightLas Pattern Scanning System - TruScan Pro?
LightLas Pattern Scanning System - TruScan Pro is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Light-Med(Usa), Inc.. The 510(k) number is K190448.
When did LightLas Pattern Scanning System - TruScan Pro receive FDA 510(k) clearance?
LightLas Pattern Scanning System - TruScan Pro received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190448.
Who is the listed applicant for LightLas Pattern Scanning System - TruScan Pro?
The FDA 510(k) record lists Light-Med(Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LightLas Pattern Scanning System - TruScan Pro?
The FDA product code for LightLas Pattern Scanning System - TruScan Pro is HQF.
相关临床试验
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相关器械（代码：HQF）
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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