FDA 510(k) Application Details - K182862

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K182862
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	Maquet Critical Care AB Rontgenvagen 2 Solna SE-171 54 SE Other 510(k) Applications for this Company
Contact	Elise Brun 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	10/11/2018
Decision Date	10/21/2019
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