FDA 510(k) Application Details - K251611

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K251611
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Fisher & Paykel Healthcare Ltd 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	868.5450   More FDA Info for this Regulation Number
Classification Product Code	BTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2025
Decision Date	06/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review