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510(k) K251584

Medical Mesh Nebulizer (AirICU Max+) by AIRICU, Inc. — Product Code SFP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 12, 2026
Date Received: May 23, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ventilator-Compatible Nebulizer
Device Class: Class II
Regulation Number: 868.5630
Review Panel: AN
Submission Type

The device is intended to deliver nebulized medications through a ventilator breathing circuit.