FDA 510(k) Application Details - K212644

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K212644
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Invictus Lighting 1401 Main Ave. SW Hickory, NC 28602 US Other 510(k) Applications for this Company
Contact	Neeraj Lal 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	08/20/2021
Decision Date	05/26/2022
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