FDA 510(k) Application Details - K230483

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K230483
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	Passy-Muir, Inc. 17992 Mitchell So., Suite 200 Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Donna Malter Other 510(k) Applications for this Contact
Regulation Number	868.5260   More FDA Info for this Regulation Number
Classification Product Code	CAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2023
Decision Date	09/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review