FDA 510(k) Application Details - K161468

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K161468
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Transformair, LLC 3802 Spectrum Blvd Suite 143 Tampa, FL 33612 US Other 510(k) Applications for this Company
Contact	Jaya Rao 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	05/27/2016
Decision Date	02/08/2017
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	Y
Expedited Review