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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K232642
Device Name AirKEE T900
Applicant
Healkee Medical Pte, Ltd.
11 N. Buona Vista Dr.
Level 08-09, The Metropolis Towel 2
Singapore,  SG 138589
Applicant Contact William Tao
Correspondent
Charles & International, LLC
45 Ashford St.
Allston,  MA  02134
Correspondent Contact Shanshan Liu
Regulation Number880.6500
Classification Product Code
FRA  
Date Received08/30/2023
Decision Date 05/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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