Hushd Avera
K号: K252161 · 2025-11-25
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决定日期2025-11-25
产品代码LRK
咨询委员会DE
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决定实质等同
器械摘要
Hushd Avera is the device name listed in this FDA 510(k) record. The listed applicant is Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252161. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hushd Avera?
Hushd Avera is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Good Sleep CO Pte , Ltd.. The 510(k) number is K252161.
When did Hushd Avera receive FDA 510(k) clearance?
Hushd Avera received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252161.
Who is the listed applicant for Hushd Avera?
The FDA 510(k) record lists Good Sleep CO Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hushd Avera?
The FDA product code for Hushd Avera is LRK.
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。
列明Good Sleep CO 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：LRK）
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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