FDA 510(k) Application Details - K212824

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K212824
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Bluezone Products, Inc. 225 Wildwood Avenue Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Karen Benedek 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	09/03/2021
Decision Date	02/17/2022
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