REMY 医疗激光治疗系统
K号: K190034 · 2019-05-15
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决定日期2019-05-15
产品代码PDZ
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
REMY Medical Therapy Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Footdocprenur, LLC. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K190034. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the REMY Medical Therapy Laser System?
REMY Medical Therapy Laser System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Footdocprenur, LLC. The 510(k) number is K190034.
When did REMY Medical Therapy Laser System receive FDA 510(k) clearance?
REMY Medical Therapy Laser System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K190034.
Who is the listed applicant for REMY Medical Therapy Laser System?
The FDA 510(k) record lists Footdocprenur, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REMY Medical Therapy Laser System?
The FDA product code for REMY Medical Therapy Laser System is PDZ.
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相关器械（代码：PDZ）
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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