FDA 510(k) Application Details - K241339

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K241339
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	Besmed Health Business Corp No. 5, Lane 116 Wu-Kong 2nd Rd. New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Sarah Lu 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	05/13/2024
Decision Date	11/14/2024
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	N
Expedited Review