FDA 510(k) Application Details - K221994

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K221994
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland 1010 NZ Other 510(k) Applications for this Company
Contact	Tara Creaven-Capasso 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	07/06/2022
Decision Date	10/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review