FDA 510(k) Application Details - K234134

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K234134
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	ResMed Pty Ltd (Registration Number: 3004604967) 1 Elizabeth Macarthur Drive Bella Vista 2153 AU Other 510(k) Applications for this Company
Contact	Shu-Ying Huang Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2023
Decision Date	09/24/2024
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