FDA 510(k) Application Details - K220990

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K220990
Device Name	Cleaner, Air, Medical Recirculating
Applicant	Winix Inc. 80-13, Sujeong-ro, Jangan-myeon Hwaseong-si 18583 KR Other 510(k) Applications for this Company
Contact	Daewoon Kang 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	04/04/2022
Decision Date	09/14/2022
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