Smileyscope 系统（治疗模式）
K号: K230825 · 2023-09-25
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决定日期2023-09-25
产品代码QRA
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Smileyscope System (Therapy Mode) is the device name listed in this FDA 510(k) record. The listed applicant is Smileyscope Holding, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K230825. The device is classified under product code QRA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Smileyscope System (Therapy Mode)?
Smileyscope System (Therapy Mode) is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Smileyscope Holding, Inc.. The 510(k) number is K230825.
When did Smileyscope System (Therapy Mode) receive FDA 510(k) clearance?
Smileyscope System (Therapy Mode) received FDA 510(k) clearance on 2023-09-25, under 510(k) number K230825.
Who is the listed applicant for Smileyscope System (Therapy Mode)?
The FDA 510(k) record lists Smileyscope Holding, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Smileyscope System (Therapy Mode)?
The FDA product code for Smileyscope System (Therapy Mode) is QRA.
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：QRA）
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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