AIO呼吸
K号: K233754 · 2024-02-23
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申请人Aiomega, LLC
决定日期2024-02-23
产品代码LQZ
咨询委员会DE
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决定实质等同
器械摘要
AIO Breathe is the device name listed in this FDA 510(k) record. The listed applicant is Aiomega, LLC. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K233754. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AIO Breathe?
AIO Breathe is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Aiomega, LLC. The 510(k) number is K233754.
When did AIO Breathe receive FDA 510(k) clearance?
AIO Breathe received FDA 510(k) clearance on 2024-02-23, under 510(k) number K233754.
Who is the listed applicant for AIO Breathe?
The FDA 510(k) record lists Aiomega, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AIO Breathe?
The FDA product code for AIO Breathe is LQZ.
相关临床试验
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列明Aiomega, 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：LQZ）
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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