FDA 510(k) Application Details - K221540

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K221540
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Synexis, LLC 11711 W. 79th Street Lenexa, KS 66214 US Other 510(k) Applications for this Company
Contact	Athena Hansen 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	05/27/2022
Decision Date	06/14/2023
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