FDA 510(k) Application Details - K211560

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K211560
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland 2013 NZ Other 510(k) Applications for this Company
Contact	Reena Daken 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	05/20/2021
Decision Date	12/10/2021
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