医用雾化器（AirICU Max+）
K号: K251584 · 2026-03-12
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申请人AIRICU, Inc.
决定日期2026-03-12
产品代码SFP
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Medical Mesh Nebulizer (AirICU Max+) is the device name listed in this FDA 510(k) record. The listed applicant is AIRICU, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K251584. The device is classified under product code SFP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Medical Mesh Nebulizer (AirICU Max+)?
Medical Mesh Nebulizer (AirICU Max+) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is AIRICU, Inc.. The 510(k) number is K251584.
When did Medical Mesh Nebulizer (AirICU Max+) receive FDA 510(k) clearance?
Medical Mesh Nebulizer (AirICU Max+) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K251584.
Who is the listed applicant for Medical Mesh Nebulizer (AirICU Max+)?
The FDA 510(k) record lists AIRICU, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Mesh Nebulizer (AirICU Max+)?
The FDA product code for Medical Mesh Nebulizer (AirICU Max+) is SFP.
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。
相关器械（代码：SFP）
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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