FDA 510(k) Application Details - K181405

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K181405
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland 1010 NZ Other 510(k) Applications for this Company
Contact	Chris Mander 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	05/29/2018
Decision Date	12/10/2018
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