FDA 510(k) Application Details - K232642

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K232642
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	HealKEE Medical Pte Ltd 11 North Buona Vista Drive Level 08-09, The Metropolis Towel 2 Singapore 138589 SG Other 510(k) Applications for this Company
Contact	William Tao 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	05/23/2024
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