FDA 510(k) Application Details - K201220

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K201220
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Aerus Medical LLC 14841 Dallas Parkway, Suite 500, The Aberdeen Bldg. Dallas, TX 75254 US Other 510(k) Applications for this Company
Contact	Andrew Eide Other 510(k) Applications for this Contact
Regulation Number	880.6500   More FDA Info for this Regulation Number
Classification Product Code	FRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2020
Decision Date	06/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review