FDA 510(k) Application Details - K211507

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K211507
Device Name	Cleaner, Air, Medical Recirculating
Applicant	Beiang Air Tech LTD. 175#, Songbei Road, Suzhou Industrial Park Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Yan Zhang Other 510(k) Applications for this Contact
Regulation Number	880.5045   More FDA Info for this Regulation Number
Classification Product Code	FRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2021
Decision Date	11/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review