FDA 510(k) Application Details - K250022

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K250022
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Voluntis 58 Avenue de Wagram Paris 75017 FR Other 510(k) Applications for this Company
Contact	Sana Charnine Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2025
Decision Date	06/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review