FDA 510(k) Application Details - K210352

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K210352
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	Great Group Medical Co., Ltd. No. 168, Xingong 2nd Rd., Tianzhong Township Changhua County 520 TW Other 510(k) Applications for this Company
Contact	Kiki Hung 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	02/08/2021
Decision Date	03/27/2022
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