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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hyperthermia Monitor
510(k) Number K240933
Device Name CarbonCool® System
Applicant
Global Healthcare SG Sdn. Bhd
Lot 43824, Jln Tech Valley 2/1, Bandar Sri Sendayan
Seremban
Negeri Sembilan,  MY 71950
Applicant Contact Keng Liang Cheng
Correspondent
Global Healthcare SG Sdn. Bhd
Lot 43824, Jln Tech Valley 2/1, Bandar Sri Sendayan
Seremban
Negeri Sembilan,  MY 71950
Correspondent Contact Keng Liang Cheng
Regulation Number870.5900
Classification Product Code
NZE  
Date Received04/05/2024
Decision Date 03/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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