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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K260270
Device Name FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
Applicant
FindAir Sp. z o.o.
Glogowa 26
Kraków,  PL 31-235
Applicant Contact Anna Pawlik
Correspondent
Pure Global
11 Town Sq. Pl., Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Oliver Eikenberg
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/28/2026
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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