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510(k) K260270

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) by FindAir Sp. z o.o. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2026
Date Received
January 28, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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