Sonix Health
K号: K230209 · 2023-10-20
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器械摘要
Sonix Health is the device name listed in this FDA 510(k) record. The listed applicant is Ontact Health Co., Ltd.. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K230209. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sonix Health?
Sonix Health is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Ontact Health Co., Ltd.. The 510(k) number is K230209.
When did Sonix Health receive FDA 510(k) clearance?
Sonix Health received FDA 510(k) clearance on 2023-10-20, under 510(k) number K230209.
Who is the listed applicant for Sonix Health?
The FDA 510(k) record lists Ontact Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonix Health?
The FDA product code for Sonix Health is QIH.
相关临床试验
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列明Ontact Health Co., Ltd.为申报人的其他记录
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：QIH）
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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