FDA 510(k) Application Details - K173367

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K173367
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Trudell Medical International 725 Third Street London n5V 5G4 CA Other 510(k) Applications for this Company
Contact	Marianne Tanton 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	10/26/2017
Decision Date	02/28/2018
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