FDA 510(k) Application Details - K232645

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K232645
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Airgle Corporation 1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 US Other 510(k) Applications for this Company
Contact	Jerry Liu 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	08/30/2023
Decision Date	02/16/2024
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