Aevice Wheeze Detection Module
K号: K260140 · 2026-09-25
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器械摘要
Aevice Wheeze Detection Module is the device name listed in this FDA 510(k) record. The listed applicant is Aevice Health Pte. , Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K260140. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aevice Wheeze Detection Module?
Aevice Wheeze Detection Module is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Aevice Health Pte. , Ltd.. The 510(k) number is K260140.
When did Aevice Wheeze Detection Module receive FDA 510(k) clearance?
Aevice Wheeze Detection Module received FDA 510(k) clearance on 2026-09-25, under 510(k) number K260140.
Who is the listed applicant for Aevice Wheeze Detection Module?
The FDA 510(k) record lists Aevice Health Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aevice Wheeze Detection Module?
The FDA product code for Aevice Wheeze Detection Module is PHZ.
相关临床试验
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列明Aevice Health Pte. , 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：PHZ）
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。
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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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