Medical Mesh Nebulizer (AirICU Max+)
K-Number: K251584 · 2026-03-12
ApplicantAIRICU, Inc.
Decision Date2026-03-12
Product CodeSFP
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Medical Mesh Nebulizer (AirICU Max+) is a medical device manufactured by AIRICU, Inc.. It received FDA 510(k) clearance on 2026-03-12 under approval number K251584. The device is classified under product code SFP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by AIRICU, Inc.. The 510(k) number is K251584.
When was Medical Mesh Nebulizer (AirICU Max+) approved by the FDA?
Medical Mesh Nebulizer (AirICU Max+) received FDA 510(k) clearance on 2026-03-12, under approval number K251584.
What company makes Medical Mesh Nebulizer (AirICU Max+)?
Medical Mesh Nebulizer (AirICU Max+) is manufactured by AIRICU, Inc..
What is the FDA product code for Medical Mesh Nebulizer (AirICU Max+)?
The FDA product code for Medical Mesh Nebulizer (AirICU Max+) is SFP.
Related Devices (Code: SFP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.