ZQuiet高级
K号: K213088 · 2022-06-15
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决定日期2022-06-15
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
ZQuiet Advance is the device name listed in this FDA 510(k) record. The listed applicant is Sleeping Well, LLC. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K213088. 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 ZQuiet Advance?
ZQuiet Advance is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Sleeping Well, LLC. The 510(k) number is K213088.
When did ZQuiet Advance receive FDA 510(k) clearance?
ZQuiet Advance received FDA 510(k) clearance on 2022-06-15, under 510(k) number K213088.
Who is the listed applicant for ZQuiet Advance?
The FDA 510(k) record lists Sleeping Well, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZQuiet Advance?
The FDA product code for ZQuiet Advance 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Sleeping Well, LLC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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