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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K243060
Device Name TeleRPM Gen2 Blood Glucose Monitoring System
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, # 105, Dongli Rd.,
Torch Development District
Zhongshan,  CN 528437
Applicant Contact Qian Mark
Correspondent
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, # 105, Dongli Rd.,
Torch Development District
Zhongshan,  CN 528437
Correspondent Contact Mark Qian
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/27/2024
Decision Date 01/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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