FDA 510(k) Application Details - K243917

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K243917
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
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	868.5330   More FDA Info for this Regulation Number
Classification Product Code	BZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2024
Decision Date	07/14/2025
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